FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
- Recall number
- Z-0139-2013
- Recalling firm
- Encore Medical, Lp
- Product
- 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
- Status
- Terminated
- Initiated
- 2012-09-28
- Posted
- 2012-10-25
- Terminated
- 2013-01-25
- Reason
- A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. It was thought that all of these screws were found in-house and were contained, but it was determined later that on
- Root cause
- Labeling mix-ups
- Action
- Encore Medical sent a Urgent Field Safety Notice dated September 28, 2012, to all affected customers. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please contact Customer Service to place a replacement order and receive an RMA number. Return all affected devices using the RMA number. For further questions please call (512) 834-6255
- Quantity
- 1 unit
- Distribution
- Nationwide Distribution only to CA.
- Lot, serial or model codes
- Model Number 10-55-025, Lot Number 006A1057.
- 510(k) numbers
- ["K931665"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- 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