Browse Device Recalls
335 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 335 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 335 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 19, 2019 | TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - ... | Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com... | Class II | Howmedica Osteonics Corp. |
| Aug 19, 2019 | TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - P... | Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com... | Class II | Howmedica Osteonics Corp. |
| Aug 19, 2019 | TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal A... | Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com... | Class II | Howmedica Osteonics Corp. |
| Aug 19, 2019 | TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - ... | Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com... | Class II | Howmedica Osteonics Corp. |
| Jun 18, 2019 | Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm... | Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the re... | Class II | Howmedica Osteonics Corp. |
| Nov 28, 2018 | Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Int... | The surgical technique is being updated to caution against misuse due to reports of cage fracture... | Class II | Howmedica Osteonics Corp. |
| Nov 26, 2018 | Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blu... | Instead of having a spherical diameter, the probe was observed to have 2 radii and a flat surface... | Class II | Howmedica Osteonics Corp. |
| Nov 15, 2018 | HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE | Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19 | Class II | Howmedica Osteonics Corp. |
| Nov 15, 2018 | HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE | Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19 | Class II | Howmedica Osteonics Corp. |
| Sep 12, 2018 | Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Pro... | The firm received complaints related to the locking mechanism on the steerable inserter not funct... | Class II | Howmedica Osteonics Corp. |
| Sep 10, 2018 | Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm... | Potential for outer pouch sterile barrier to be compromised | Class II | Howmedica Osteonics Corp. |
| May 22, 2018 | LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-136 | The recalling firm has received a higher than expected number of complaints documenting femoral h... | Class II | Howmedica Osteonics Corp. |
| May 22, 2018 | LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236 | The recalling firm has received a higher than expected number of complaints documenting femoral h... | Class II | Howmedica Osteonics Corp. |
| May 22, 2018 | LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-140 | The recalling firm has received a higher than expected number of complaints documenting femoral h... | Class II | Howmedica Osteonics Corp. |
| May 22, 2018 | LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-144 | The recalling firm has received a higher than expected number of complaints documenting femoral h... | Class II | Howmedica Osteonics Corp. |
| May 22, 2018 | LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336 | The recalling firm has received a higher than expected number of complaints documenting femoral h... | Class II | Howmedica Osteonics Corp. |
| May 22, 2018 | LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-044 | The recalling firm has received a higher than expected number of complaints documenting femoral h... | Class II | Howmedica Osteonics Corp. |
| May 22, 2018 | LFIT Anatomic CoCr Femoral Heads, 6260-9-036 | The recalling firm has received a higher than expected number of complaints documenting femoral h... | Class II | Howmedica Osteonics Corp. |
| May 22, 2018 | LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040 | The recalling firm has received a higher than expected number of complaints documenting femoral h... | Class II | Howmedica Osteonics Corp. |
| Jan 30, 2018 | Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The kn... | Customers may receive the incorrect size implant from what is labeled on the box. | Class II | Howmedica Osteonics Corp. |
| Jan 12, 2018 | Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee syst... | Firm became aware that the specific product/lot combinations referenced above may contain the inc... | Class II | Howmedica Osteonics Corp. |
| Dec 21, 2017 | Custom Made Implant System with Minimum Invasive Grower (MIG) component | From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to cl... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Recon Stem Implant Plasma Coated, Size 1. Orthopedic implant for replac... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead, Radial Implant 6 mm Collar, Size 1. Orthopedic implant for replacemen... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Recon Stem Implant 6mm Collar, Size 4. Orthopedic implant for replaceme... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Radio Capitellum Small, Right. Orthopedic implant for replacement of the pro... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Standard Extended Stem, 6mm Collar, Size 1. Orthopedic implant for rep... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead, Radial Implant 6 mm Collar, Size 3. Orthopedic implant for replacemen... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for repl... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Recon Stem Implant 6mm Collar, Size 2. Orthopedic implant for replaceme... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Recon Extended Stem Size 2. Orthopedic implant for replacement of the ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | radial stem implant #2 (Sterile packed). Orthopedic implant for replacement ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement o... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lateral Assembly, Radial Stem Implant, Size 4. Orthopedic implant for replace... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lateral Assembly, Radial Stem Implant, Size 3. Orthopedic implant for replace... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4. Orthopedic implant for repl... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | radial head implant #2 (Sterile packed). Orthopedic implant for replacement ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Radial Head Assy Size #2, Rad. Orthopedic implant for replacement of the pro... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Radial Head Assy Size #3, Rad. Orthopedic implant for replacement of the pro... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. Orthopedic implant for repl... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Recon Stem Implant non-coated, Size 3. Orthopedic implant for replacem... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | radial stem implant #4 (Sterile packed). Orthopedic implant for replacement ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | radial head implant #3 (Sterile packed). Orthopedic implant for replacement ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Standard Extended Stem, 6mm Collar, Size 3. Orthopedic implant for rep... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | Lateral Assembly, Radial Stem Implant, Size 2. Orthopedic implant for replace... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
| Oct 24, 2017 | rHead Stem Implant 6mm Collar, Size 1. Orthopedic implant for replacement of ... | Revision rate identified as higher than other proximal radial head replacement devices based on l... | Class II | Howmedica Osteonics Corp. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.