FDA Medical Device Recalls (openFDA)
Wright Medical Technology Inc: Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3654, Size 54mm O.D., use with 36 mm Head
- Recall number
- Z-0572-2007
- Recalling firm
- Wright Medical Technology Inc
- Product
- Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3654, Size 54mm O.D., use with 36 mm Head
- Status
- Terminated
- Initiated
- 2007-01-03
- Posted
- 2007-03-07
- Terminated
- 2009-01-15
- Reason
- Product specification failure which could result in improper locking of the cup onto the femoral head.
- Root cause
- Other
- Action
- The firm initiated the recall by telephoning its distributors on January 3, 2007 to request the return of the products. They followed with letters (mailed 1/15/07) to hospitals, implanting surgeons, and distributors requesting return of the product and informing them of the revision surgery that was a result of the problem.
- Quantity
- 14 units
- Distribution
- Nationwide and Japan
- Lot, serial or model codes
- Lot Nos.: 106381256, 106382092
- 510(k) numbers
- ["K062693"]
- PMA numbers
- not on file
- Product code
- KWY
- Firm FEI
- 1043534
- Firm city
- Arlington
- Firm state
- TN
- 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