FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0316-2007
- Recalling firm
- 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.
- Status
- Terminated
- Initiated
- 2006-09-15
- Posted
- 2006-12-27
- Terminated
- 2008-06-11
- 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.
- Lot, serial or model codes
- Lot #P0835-1
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAD
- Firm FEI
- 3002477077
- Firm city
- St. Louis
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28