Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 6501–6520 of 38,428 recalls

December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product...

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part...

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: DUR PCA MTK REV INS LFT Intended for knee replacement

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: DUR PCA MTK REV INS LFT Intended for knee replacement

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 1, 2023· Howmedica Osteonics Corp.

Recalled Item: PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement

The Issue: Product manufactured using UHMWPE raw material over 5

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing