PATIENT SPECIFIC INSTRUMENTS N-K FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE Patient
FDA device recall Z-1544-2012 · posted 2012-05-14 · Terminated
Recall details
- Recalling firm
- Materialise USA LLC
- Reason for recall
- March 23, 2012 a field representative reported patient specific --0242 L tibia guide case packaging contained a different patient specific ..-0864-R tibia guide. The two patient specific products had been switched in packaging. Neither products had been delivered to the end user.
- Action taken
- Materialise telephoned both field representatives on March 23, 2012 and confirmed recalled product mix-up. Materialise requested both cases be returned and replacements were provided. No affected product was received by the end user.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 1 unit
- Distribution
- Nationwide Distribution including the states of Ohio and Minnesota.
- Date initiated
- 2012-03-23
- Date posted
- 2012-05-14
- Date terminated
- 2013-01-23
- Location
- Plymouth, MI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS (K111492) | Materialise NV | 2011-10-13 |