FDA Medical Device Recalls (openFDA)
Plus Orthopedics USA: VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121
- Recall number
- Z-0361-2008
- Recalling firm
- Plus Orthopedics USA
- Product
- VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121
- Status
- Terminated
- Initiated
- 2006-11-13
- Posted
- 2007-12-08
- Terminated
- 2007-12-13
- Reason
- Labeling Error: The VKS PE Ultra-congruent insert package, may actually contain a Standard PE insert.
- Root cause
- Employee error
- Action
- Consignees were notified by telephone on 11/13/2006 to check their inventory and return any affected units. On 11/28/06 Physician Notifications and Patient Assessment forms were sent to the two physicians who had implanted a total of 4 devices.
- Quantity
- 10
- Distribution
- Nationwide: USA including states of ID, NY, VA & WI
- Lot, serial or model codes
- Model Number: 0214612, Lot Number: 044159 No serial numbers
- 510(k) numbers
- ["K022204"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3001237832
- Firm city
- San Diego
- Firm state
- CA
- 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