Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640.
FDA device recall Z-0918-05 · posted 2005-06-22 · Terminated
Recall details
- Recalling firm
- EBI, L.P.
- Reason for recall
- The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire.
- Action taken
- The firm distributed a recall letter to their EBI Fracture Sales Representatives and their EBI Trauma Distributors on 3/16/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- HXI
- Quantity affected
- 152 units
- Distribution
- These devices are distributed nationwide to sales representatives who provide the product directly to the hospital/physician at the time of the surgery. The product was also distributed to Italy and S
- Date initiated
- 2005-03-16
- Date posted
- 2005-06-22
- Date terminated
- 2006-06-30
- Location
- Parsippany, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES (K982953) | Biomet, Inc. | 1998-10-21 |