Artificial ligament fixation device # 7PE ZIPLOOP Extended Toggle, Sterile, REF 904755, Biomet Sports Medicine Warsaw, I
FDA device recall Z-1952-2010 · posted 2010-07-01 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The firm has received complaints that the saddle is too long. The saddle is supposed to be between 7/8 and 1 1/8 inches long. The saddle in the complaints was up to 1.9 inches long.
- Action taken
- Biomet Sports Medicine issued an "Urgent Medical Device Recall Notice" dated March 31, 2010 to user facilities and distributors. A second notification containing updated information was issued June 2, 2010. Consignees were instructed to discontinue use of the product and return it to the firm along with a completed Response Form. For further information, contact Biomet at 1-574-371-3755 or 1-574-371-3756, Monday through Friday, 8AM to 5PM.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MBI
- Quantity affected
- 2466 both products
- Distribution
- Worldwide Distribution -- United States, Canada, Australia, The Netherlands, Belgium, Italy, France, New Zealand, Austria, United Kingdom, Chile, Greece, Poland, Denmark, Turkey, Portugal, South Afric
- Date initiated
- 2010-03-31
- Date posted
- 2010-07-01
- Date terminated
- 2012-08-06
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TOGGLELOC SYSTEM (K083070) | Biomet Sports Medicine | 2008-12-16 |