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Browse Device Recalls

1,125 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,125 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 1,125 FDA device recalls.

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DateProductReasonClassFirm
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 9MM X 400MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 ... There is a potential for intermittent cracks in the raw material batch used to produce the affect... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 1, 2017 Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a... The products being recalled exceeded the weight previously tested leading to a possibility of dam... Class II Zimmer Biomet, Inc.
Aug 1, 2017 Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT... The products being recalled exceeded the weight previously tested leading to a possibility of dam... Class II Zimmer Biomet, Inc.
Jul 5, 2017 Persona Partial Knee System, Size 8, Finishing Guide Finishing guide does not adequately account for shape differences present in Size 8 of Persona Pa... Class II Zimmer Biomet, Inc.
Jun 30, 2017 DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty Product may contain the presence of melted sterile packaging upon opening. Class II Zimmer Biomet, Inc.
Jun 30, 2017 JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty For soft tissue fixation Class II Zimmer Biomet, Inc.
Jun 29, 2017 PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plas... Device was distributed with the etching missing from the product. Class II Zimmer Biomet, Inc.
Jun 16, 2017 ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem ... Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with S... Class II Zimmer Biomet, Inc.
Jun 12, 2017 DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE A raw material anomaly was discovered in four lots of raw material and has the potential to be on... Class II Zimmer Biomet, Inc.
Jun 5, 2017 ECHO POR FMRL NC 9X125, model # 192009 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Lateral Troch Plate Full Crimp - 254mm, model # 350837 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 CER BIOLOXD OPTION HD 32MM, model # 650-1056 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 COMP PRIMARY STEM 8MM MINI, model # 113628 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm lengt... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 OSS CEMENTED IM STEM 12X150, model # 150366 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm lengt... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 COMP 12MM HUM FRAC STEM MACRO, model # 11-113562 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Lateral Troch Plate Full Crimp - 254mm, model # 350838 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter ... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 c... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
May 22, 2017 Drill Bit Quick-Connect 1.5 mm Diameter 85 mm Length, Item Number/EDI 0048060... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill 1.5 mm Diameter (.059 Inch), Item Number... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Zimmer Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 mm Length, It... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill Bits 3.2 mm Diameter (.126 Inch), Item N... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Co... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 mm Diameter, Item Num... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill 4.5 mm Diameter (.177 Inch), Item Number... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Straight Shank Drill Bit 4.0 mm Diameter, Item Number/EDI 00231804000, Nonste... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill 2.7 mm Diameter (.106 Inch), Item Number... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill 2.5 mm Diameter (.098 Inch), Item Number... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 11 cm Leng... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Quick-Connect Drill 3.5 mm Diameter 11 cm Leng... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Drill Bit Jacobs Chuck 3.2 mm Diameter 130 mm Length, Item Number/EDI 0048051... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill 2.0 mm Diameter (.079 Inch), Item Number... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 Straight Shank Drill Bits 4.0 mm Diameter, Item Number/EDI 00231804006, Nonst... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, Inc.
May 22, 2017 ECT Internal Fracture Fixation Drill Bits 4.5 mm Diameter (.177 Inch), Item N... Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw m... Class II Zimmer Biomet, 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.