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.
This recall has been terminated (originally issued December 27, 2006).
- Company
- Whiteside Biomechanics
- Recall Initiated
- September 15, 2006
- Posted
- December 27, 2006
- Terminated
- June 11, 2008
- Recall Number
- Z-0316-2007
- Quantity
- 10 retractors (5 right, 5 left)
- Firm Location
- St. Louis, MO
- Official Source
- View on FDA website ↗
Reason for Recall
The soft tissue pin in the retractor can break off and become embedded in the tissue.
Distribution
Distribution was made to two hospitals, one in MD and the other in MO.
Lot / Code Info
Lot #P0835-1
Root Cause
Other
Action Taken
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.