Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrume
FDA device recall Z-0418-2015 · posted 2014-11-21 · Terminated
Recall details
- Recalling firm
- Materialise USA LLC
- Reason for recall
- The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.
- Action taken
- Materialise USA was notified on October 16, 2014 by the Field Representative of the distributor (Zimmer) that the box of guides for case JTOMA-JL-0636-L arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. A new set of tibial and femoral guides were manufactured and sent to Zimmer (headquarters distribution center) on October 17, 2014 before the surgery date on October 20, 2014. For questions regarding this recall call 734-662-5057.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 1
- Distribution
- Nationwide Distribution to MN only
- Date initiated
- 2014-10-16
- Date posted
- 2014-11-21
- Date terminated
- 2015-02-17
- Location
- Plymouth, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM (K121640) | Materialise NV | 2012-12-05 |