Browse Device Recalls
2,549 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,549 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 2,549 FDA device recalls in IN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 28, 2013 | C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx onl... | Product not cleared for sale/use in the United States. | Class II | Camlog Usa |
| Aug 28, 2013 | C2244.4308 CONELOG Titanium Base CC ¿4.3GH2 0.8 inkl HS Product Usage: En... | Product not cleared for sale/use in the United States. | Class II | Camlog Usa |
| Aug 28, 2013 | Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates Th... | Zimmer recently conducted a review of historic packaging validations completed. Based on this re... | Class II | Zimmer, Inc. |
| Aug 26, 2013 | Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, ... | Possibility of the weld to the quick-connect breaking when force is applied to the handle for pe... | Class II | Zimmer, Inc. |
| Aug 19, 2013 | ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction wit... | Internal Roche inspections have revealed that after the lancet is used for a finger stick, the ne... | Class II | Roche Diagnostics Operations, Inc. |
| Aug 1, 2013 | 00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, ... | Zimmer is initiating a lot specific recall of the Trabecular Metal" Reverse Glenosphere Distracto... | Class II | Zimmer, Inc. |
| Jul 30, 2013 | ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLAT... | Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, ... | Class II | Zimmer, Inc. |
| Jul 24, 2013 | 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System ... | OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #913... | Class II | OrthoPediatrics Corp |
| Jul 16, 2013 | Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Ste... | Zimmer recently conducted a review of historic packaging validations completed. Based on this re... | Class II | Zimmer, Inc. |
| Jul 11, 2013 | LPS Lower Extremity Dovetail Intercalary component. Intended for use in re... | The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the fema... | Class I | DePuy Orthopaedics, Inc. |
| Jun 28, 2013 | REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, ... | There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to frac... | Class II | Zimmer, Inc. |
| Jun 28, 2013 | REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, ... | There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to frac... | Class II | Zimmer, Inc. |
| Jun 19, 2013 | VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 m... | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... | Class II | Zimmer, Inc. |
| Jun 19, 2013 | VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and shor... | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... | Class II | Zimmer, Inc. |
| Jun 19, 2013 | Free Lock Femoral Hip Fixation System Compression Tube/Plate, different lengt... | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... | Class II | Zimmer, Inc. |
| Jun 19, 2013 | Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths... | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... | Class II | Zimmer, Inc. |
| Jun 19, 2013 | VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and shor... | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... | Class II | Zimmer, Inc. |
| Jun 11, 2013 | Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12m... | The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4... | Class II | Zimmer, Inc. |
| Jun 10, 2013 | Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provi... | Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface... | Class II | Zimmer, Inc. |
| Jun 10, 2013 | Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provi... | Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface... | Class II | Zimmer, Inc. |
| Jun 10, 2013 | Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Prov... | Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface... | Class II | Zimmer, Inc. |
| Jun 10, 2013 | Persona (TM) The Personalized Knee System Tibial Articular Surface Provisio... | Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface... | Class II | Zimmer, Inc. |
| Jun 10, 2013 | Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provi... | Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface... | Class II | Zimmer, Inc. |
| Jun 10, 2013 | Persona (TM) The Personalized Knee System Tibial Articular Surface Provisio... | Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | 90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17, Rx, Sterile; ... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | 00597001131 Femur CR PRC SURF HDN FEM CO-N... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | 65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile; 65597201132 ... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | REF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F4... | Biomet investigation found the design of the tibial bearing creates the potential for anterior im... | Class II | Biomet, Inc. |
| Jun 7, 2013 | REF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E5... | Biomet investigation found the design of the tibial bearing creates the potential for anterior im... | Class II | Biomet, Inc. |
| Jun 7, 2013 | 90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17, Rx, Sterile; ... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | REF 154214 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C3... | Biomet investigation found the design of the tibial bearing creates the potential for anterior im... | Class II | Biomet, Inc. |
| Jun 7, 2013 | REF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B3... | Biomet investigation found the design of the tibial bearing creates the potential for anterior im... | Class II | Biomet, Inc. |
| Jun 7, 2013 | 00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10, Rx, Sterile; ... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | 00595001201 Femur CR-FLEX PCT FEM B-L Rx, Sterile; 0059500... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | REF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6... | Biomet investigation found the design of the tibial bearing creates the potential for anterior im... | Class II | Biomet, Inc. |
| Jun 7, 2013 | 00595201201 Femur CR-FLEX POR FEM B-L Rx, Sterile; 00595201202 Femur CR-F... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | 00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile; 00587806129... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3... | Biomet investigation found the design of the tibial bearing creates the potential for anterior im... | Class II | Biomet, Inc. |
| Jun 7, 2013 | 00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx, Sterile; 00597... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | 65597201333 Femur CR POR FEM SURF HDN HATCP CML, Rx, Sterile; 65597201334 ... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | REF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D3... | Biomet investigation found the design of the tibial bearing creates the potential for anterior im... | Class II | Biomet, Inc. |
| Jun 7, 2013 | 00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10, Rx, Sterile; 005... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | REF 154202 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A5... | Biomet investigation found the design of the tibial bearing creates the potential for anterior im... | Class II | Biomet, Inc. |
| Jun 7, 2013 | REF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6A... | Biomet investigation found the design of the tibial bearing creates the potential for anterior im... | Class II | Biomet, Inc. |
| Jun 7, 2013 | REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4... | Biomet investigation found the design of the tibial bearing creates the potential for anterior im... | Class II | Biomet, Inc. |
| Jun 7, 2013 | 00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9, Rx, Sterile; ... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | REF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4... | Biomet investigation found the design of the tibial bearing creates the potential for anterior im... | Class II | Biomet, Inc. |
| Jun 7, 2013 | 00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx, Sterile; 00597... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | 00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile; 00597201304 Femur ... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ... | Class II | Zimmer, Inc. |
| Jun 7, 2013 | REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6... | Biomet investigation found the design of the tibial bearing creates the potential for anterior im... | Class II | 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.