Z-0077-2014Class II
Gender Solutions" Patello-Femoral Component
Zimmer GmbH / initiated 2013-08-30 / Terminated / root cause: packaging
Zimmer, Inc. began a recall of Gender Solutions" Patello-Femoral Component on . FDA classified it as Class II and gives the reason as "The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-0077-2014
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Gender Solutions" Patello-Femoral Component
- Product code
- KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- Reason for recall
- The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
- Root cause tag
- packaging
- FDA root cause
- Package design/selection
- Action
- August 30, 2013 Urgent Recall Notices were sent to Distributors, hospital risk managers and surgeons identifying the issue and directing consignees to make all affected personnel aware of the contents of the notification. The notice identified the products involved, the issue, possible adverse events associated with the issue and recommended that implants found with LDPE bag adhesion not use the product and return it to Zimmer sales representatives. Questions or concerns should be addressed to Zimmer customer call center at 1-877-946-2761 between the hours of 8 a.m. and 5 p.m. EST.
- Quantity in commerce
- 5103
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
- Product codes and lots
- Part Number Range:00-5926-011/015-01/02
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0068-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0069-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0070-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0071-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0072-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0073-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0074-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0075-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0076-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0077-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0078-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0079-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0080-2014 | Class II | Terminated | Voluntary: Firm initiated |
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