FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Biomet Orthopedics, Inc., Warsaw, IN.
- Recall number
- Z-0705-2008
- Recalling firm
- Biomet, Inc.
- Product
- Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Biomet Orthopedics, Inc., Warsaw, IN.
- Status
- Terminated
- Initiated
- 2007-10-18
- Posted
- 2008-02-05
- Terminated
- 2008-03-11
- Reason
- The instrument will not lock onto the impactor handle; the device was distributed without assembly of the Bal Seal component.
- Root cause
- Process control
- Action
- Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee locations.
- Quantity
- 141 total for all recalls Z-0700-0705-2008
- Distribution
- Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.
- Lot, serial or model codes
- Lot Number: 038730.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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