FDA Medical Device Recalls (openFDA)
Wright Medical Technology Inc: Profemur R, Revision Hip system, Proximal Body (part), X-Small model, REF: PPW38364, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only Hip implant.
- Recall number
- Z-0867-2007
- Recalling firm
- Wright Medical Technology Inc
- Product
- Profemur R, Revision Hip system, Proximal Body (part), X-Small model, REF: PPW38364, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only Hip implant.
- Status
- Terminated
- Initiated
- 2007-03-27
- Posted
- 2007-06-07
- Terminated
- 2008-06-30
- Reason
- The titanium plasma coating was found to have missing fragments.
- Root cause
- Other
- Action
- The firm sent out recall notices to implanting surgeons by letter dated 03/27/2007 (via FedEx) to notify the surgeons of the issue. The hospitals and distributors were also notified of the issue and given instructions for return of the product.
- Quantity
- 18 units
- Distribution
- Nationwide, Puerto Rico, & Japan
- Lot, serial or model codes
- Lot Nos.: W09356957, W09358977
- 510(k) numbers
- ["K003016"]
- PMA numbers
- not on file
- Product code
- LZO
- 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