Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156.
FDA device recall Z-0777-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The locking ring was not included and the shoulder implanted without the locking ring.
- Action taken
- The firm recovered the consigneed units from hospital stocks and issued a letter dated 2/23/04 to the two implanting physicians.
- Root cause
- Other
- Status
- Terminated
- Product code
- KWT
- Quantity affected
- 7
- Distribution
- California, Florida, Washington, Germany and Venezuela.
- Date initiated
- 2004-02-23
- Date posted
- 2004-07-20
- Date terminated
- 2004-04-13
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOMET BI-POLAR SHOULDER SYSTEM (K002998) | Biomet, Inc. | 2000-10-06 |