Recall Z-0577-2008 ยท JEB Table, Surgical With Orthopedic Accessories, Manual
Tenet Medical Engineering Inc
TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) #7691; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.
| Date | Feb 26, 2008 (initiated Nov 23, 2007) |
| Status | Terminated |
| Reason | Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised. |
| Root cause | Packaging process control |
| Action | TENET notified US distributor consignee via Urgent Product Recall Notification letter sent FedEx on 11/23/07. Consignee asked to return product and to contact their consignees to also return product. |
| Quantity | 300 units. |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.