Drug recall
CoCr Head (Not distributed in the United States) Used in total hip replacement.
FDA recall event 65799 · Class II · Zimmer, Inc.
Key facts
| Event ID | 65799 |
|---|---|
| Recall numbers | Z-0068-2014, Z-0069-2014, Z-0070-2014, Z-0071-2014, Z-0072-2014, Z-0073-2014, Z-0074-2014, Z-0075-2014, Z-0076-2014, Z-0077-2014, Z-0078-2014, Z-0079-2014 and 1 more |
| Recalling firm | Zimmer, Inc. |
| Product type | Devices |
| Products | CoCr Head (Not distributed in the United States) Used in total hip replacement., CPT¿ Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1 COCR EXT CPT 12/14 STEM SIZE 2 COCR; CPT 12/14 SIZE 2 COCR EXT; CPT 12/14 SIZE 2…, Gender Solutions" Patello-Femoral Component, Metasul¿ Head. Intended for use either with or without bone cement in total hip arthroplasty., Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip. and 8 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. |
| Initiation date | Aug 30, 2013 |
| Report date | Nov 6, 2013 |
| Termination date | Sep 25, 2014 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1000220733 |
At a glance
- 10–99 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: