Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw, Indiana; REF 8
FDA device recall Z-0993-2007 · posted 2007-07-04 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The syringe assembly has an obstruction in the tube that prevents the plunger from being depressed.
- Action taken
- Consignees were notified by letter dated either 6/11/07 or 6/13/07 and requested to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 46 to U.S. and international
- Distribution
- Worldwide, including USA, Chile, Italy, Spain and United Kingdom.
- Date initiated
- 2007-06-11
- Date posted
- 2007-07-04
- Date terminated
- 2007-12-05
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PCCS GRAFT DELIVERY SYSTEM (K021071) | Biomet, Inc. | 2002-07-01 |