Posterior Acetabular Retractor-Left with Light Cord Bracket…

Date posted by the FDA

Dec. 27, 2006

Status

Terminated

Filed by

Whiteside Biomechanics

Product

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.

Reason

The soft tissue pin in the retractor can break off and become embedded in the tissue.

Distribution pattern

Distribution was made to two hospitals, one in MD and the other in MO.

Quantity

10 retractors (5 right, 5 left)

Codes and lots

Lot #P0835-1

Recall started

Sept. 15, 2006

Device type

Retractor

Root cause (FDA)

Other

What the company told customers

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.

Recall number

Z-0316-2007

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0316-2007. The agency record governs; check it and the company before acting.