Browse Device Recalls
2,560 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,560 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 2,560 FDA device recalls in IN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 4, 2012 | Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder... | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Biolox¿ delta Ceramic Femoral Head Rx only, sterile | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Metasul¿ LDH¿ Head Rx Sterile | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Anatomical Shoulder" Fracture Humeral Head | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | MS-30¿ Proximal positioner | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | CoCr Head, sterile, Rx | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Wagner cone Prosthesis, uncemented, sterile, Rx | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Wagner SL Revision Stem, uncemented Sterile | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Alloclassic¿ SL-Offset Stem sterile, Rx | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Sirus¿ intramedullary nail for tibia, cannulated ¿ | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Dynesys¿ L.I.S. Stabilizing cord Rx, Sterile | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | NCB¿-PT lateral proximal 3 hole tibial plate | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Dynesys¿ Universal spacer 6-45 | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Dynesys¿ Set screw M6 | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Metasul¿ Durom¿ Femoral component Sterile, Rx | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | NCB¿-PH Plate | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Dynesys¿ HA Pedicle + set screw | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Fitmore" Hip Stem | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Kopf Adapter S Sterile, Rx | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | NCB¿ cancellous screw | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Anatomical Shoulder" Humeral Head | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Original M.E. Mueller" Low Profile Cup Sterile, Rx | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | CLS Stem | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | MS-30¿ Distal centralizer, cemented, sterile, Rx | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Anatomical Shoulder" Humeral stem | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | MS-30¿ Stem | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Dynesys¿ Revision + set screw | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Anatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Anatomical Shoulder" Inverse Humeral Cup | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 P... | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Biolox¿ Option Ceramic Femoral Head System Rx, sterile | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Alloclassic SL Shaft | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Anatomical Shoulder" Fracture Humeral stem | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | DTO" Implant | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | NCB¿ screw ¿ 4.0 self-tapping | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Sep 4, 2012 | Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... | Class II | Zimmer, Inc. |
| Aug 31, 2012 | Multipolar¿ Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usa... | Zimmer Inc. is initiating a removal of the Multipolar¿ Bipolar Cup Liner 22 mm J.D. (item 00-5001... | Class II | Zimmer, Inc. |
| Aug 27, 2012 | Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner ser... | Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is p... | Class II | Zimmer, Inc. |
| Aug 23, 2012 | Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia b... | King Systems received a customer complaint indicating that the customer had ordered a breathing c... | Class I | King Systems Corp. |
| Aug 23, 2012 | Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity... | Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properl... | Class II | Biomet, Inc. |
| Aug 23, 2012 | Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity... | Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properl... | Class II | Biomet, Inc. |
| Aug 22, 2012 | S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into ... | Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner becaus... | Class II | DePuy Orthopaedics, Inc. |
| Aug 14, 2012 | JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is i... | Investigation found that the current design of the product allows the press-fit of the knob/shaft... | Class II | Biomet, Inc. |
| Jul 31, 2012 | DePuy Custom Implant Devices Packaging: Packaging was not standardized o... | In connection with a Warning Letter received from the U.S. Food & Drug Administration on December... | Class II | DePuy Orthopaedics, Inc. |
| Jul 24, 2012 | Altrx" Altralinked" Polyethylene liners Description: An acetabular liner i... | In the recalled lot, the products were not machined according to the production router, a size 52... | Class II | DePuy Orthopaedics, Inc. |
| Jul 18, 2012 | 00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65¿ Neck Angle ... | Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... | Class II | Zimmer, Inc. |
| Jul 18, 2012 | 00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile Per... | Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... | Class II | Zimmer, Inc. |
| Jul 18, 2012 | Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per s... | Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... | Class II | Zimmer, Inc. |
| Jul 18, 2012 | 00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angl... | Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... | Class II | Zimmer, Inc. |
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.