Z-0316-2007

Posterior Acetabular Retractor-Left with Light Cord Bracket, Model #BIO-1-1050-A, and Posterior Acetabular...

Name: Z-0316-2007 Posterior Acetabular Retractor-Left with Light Cord Bracket, Model #BIO-1-1050-A, and Posterior Acetabular...
Creator: Whiteside Biomechanics
Published: 2006-09-15
License: https://open.fda.gov/license/

Whiteside Biomechanics, Inc. / initiated 2006-09-15 / Terminated

FDA source

Whiteside Biomechanics began a recall of Posterior Acetabular Retractor-Left with Light Cord Bracket, Model #BIO-1-1050-A, and Posterior Acetabular Retractor-Right with Light Cord Bracket, Model... on 2006-09-15. The reason FDA records is "The soft tissue pin in the retractor can break off and become embedded in the tissue". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0316-2007
Status: Terminated
Initiated: 2006-09-15
Posted: 2006-12-27
Terminated: 2008-06-11
Recalling firm: Whiteside Biomechanics, Inc.
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.
Product code: GAD Retractor
Reason for recall: The soft tissue pin in the retractor can break off and become embedded in the tissue.
FDA 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 in commerce: 10 retractors (5 right, 5 left)
Distribution: Distribution was made to two hospitals, one in MD and the other in MO.
Product codes and lots: Lot #P0835-1

Product code GAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)