Recall Z-0316-2007 ยท GAD Retractor
Whiteside Biomechanics
Posterior Acetabular Retractor-Left with Light Cord Bracket, Model #BIO-1-1050-A, and Posterior Acetabular Retractor-Right with Light Cord Bracket, Model #BIO-1-1051-A, packaged 1 retractor (left or right retractor) per plastic bag. The firm name on the label is Whiteside Biomechanics, Inc., St. Louis, MO.
| Date | Dec 27, 2006 (initiated Sep 15, 2006) |
| Status | Terminated |
| Reason | The soft tissue pin in the retractor can break off and become embedded in the tissue. |
| Root cause | Other |
| Action | The recalling firm was notified of the problem via a telephone call from the surgeon on 9/15/06 and the remaining retractors were placed in quarantine by the hospital. The recalling firm requested return of the retractors. The recalling firm immediately visited the one remaining hospital on 9/15/06 and picked up their inventory of six retractors. |
| Quantity | 10 retractors (5 right, 5 left) |
| Distribution | Distribution was made to two hospitals, one in MD and the other in MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.