Trabecular Metal acetabular revision system buttress augment size, 58, 00-4898-001-58, sterile, Zimmer Inc., Parsippany,
FDA device recall Z-2215-2010 · posted 2010-08-12 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
- Action taken
- The firm sent an "Urgent Device Removal" letter dated 4/6/2010. The consignees were instructed to inventory the products on hand and return the recalled product to the manufacturer. More information is available at 1-800-613-6131.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 1972 all products
- Distribution
- US, Germany, Brazil, Singapore, Canada, Australia, England, India, and Switzerland.
- Date initiated
- 2010-04-06
- Date posted
- 2010-08-12
- Date terminated
- 2011-10-21
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRABECULAR METAL ACETABULAR AUGMENTS (K061067) | Zimmer Trabecular | 2006-05-25 |