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Terminated

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.

FDA Recall Z-0316-2007 · Posted 2006-12-27

Recalling FirmWhiteside Biomechanics
Recall StatusTerminated
Product CodeGAD
Date Initiated2006-09-15
Date Terminated2008-06-11
Product Quantity10 retractors (5 right, 5 left)

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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