FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component.
- Recall number
- Z-2204-2010
- Recalling firm
- Biomet, Inc.
- Product
- Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component.
- Status
- Terminated
- Initiated
- 2010-04-20
- Posted
- 2010-08-10
- Terminated
- 2011-01-19
- Reason
- A knee implant labeled as left was opened and the package actually contained a right knee implant.
- Root cause
- Process control
- Action
- On 4/13, 14 and 15 Biomet made phone calls to the consignees to inform them of the recall. The firm sent Urgent Medical Device Recall Notices dated 4/20/2010. The customers were instructed to immediately locate the recalled products and return them to the manufacturer.
- Quantity
- 5
- Distribution
- 1 unit in US. 3 units in Biomet distributor inventory, 1 unit in Japan
- Lot, serial or model codes
- M402080.
- 510(k) numbers
- ["K023546"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- 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