Recall Z-1514-06 ยท JEB Table, Surgical With Orthopedic Accessories, Manual
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew Hip Positioning System Ref: 72200624 with System Components: Perineal Post 72200631 Universal Hip Distractor 72200626 Knee Holder 72200627 Well Leg Holder 72200632 Supine Table Extension 72200629
| Date | Sep 30, 2006 (initiated May 22, 2006) |
| Status | Terminated |
| Reason | The Perineal Post may crack or break and the Universal Hip Distractor (carriage) may not maintain adequate traction for the duration of the procedure |
| Root cause | Other |
| Action | Smith & Nephew notified accounts on 5/22/06 by Letter via Federal Express to User Facility and Sales Reps and follow up telephone call to the user facilities. Devices are requested to be returned. |
| Quantity | 3 |
| Distribution | Nationwide distribution ---- including states of NM, MO, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.