Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component.
FDA device recall Z-2204-2010 · posted 2010-08-10 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- A knee implant labeled as left was opened and the package actually contained a right knee implant.
- Action taken
- On 4/13, 14 and 15 Biomet made phone calls to the consignees to inform them of the recall. The firm sent Urgent Medical Device Recall Notices dated 4/20/2010. The customers were instructed to immediately locate the recalled products and return them to the manufacturer.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 5
- Distribution
- 1 unit in US. 3 units in Biomet distributor inventory, 1 unit in Japan
- Date initiated
- 2010-04-20
- Date posted
- 2010-08-10
- Date terminated
- 2011-01-19
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAXIM ACCEL KNEE SYSTEM (K023546) | Biomet, Inc. | 2003-01-17 |