NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Inten
FDA device recall Z-1325-2015 · posted 2015-03-26 · Terminated
Recall details
- Recalling firm
- Zimmer Trabecular Metal Technology, Inc.
- Reason for recall
- One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
- Action taken
- Zimmer Trabecular Metal Technology sent an email dated 12/10/2014 to their sole customer. The customer was requested to return the affected product.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MBH
- Quantity affected
- 1 unit
- Distribution
- US Distribution in the state of CA
- Date initiated
- 2015-02-04
- Date posted
- 2015-03-26
- Date terminated
- 2015-07-16
- Location
- Parsippany, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRABECULAR METAL KNEE SYSTEM AUGMENTS (K040487) | Implex Corp. | 2004-12-21 |