FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model 31-400600. Non-powered, hand-held instrument intended for use as an impactor during orthopedic surgery.
- Recall number
- Z-0181-2009
- Recalling firm
- Biomet, Inc.
- Product
- Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model 31-400600. Non-powered, hand-held instrument intended for use as an impactor during orthopedic surgery.
- Status
- Terminated
- Initiated
- 2008-07-28
- Posted
- 2008-10-24
- Terminated
- 2009-09-22
- Reason
- The pin and clip may fracture during use.
- Root cause
- Device Design
- Action
- Consignees were notified by recall letter dated 7/28/08 to remove the recalled lots from use and to return them. Contact Biomet, Inc. at 1-800-348-9500 or 1- 574-372-3983 for assistance.
- Quantity
- 85
- Distribution
- Nationwide, Australia, Belgium, Canada, Denmark, New Zealand and Sweden.
- Lot, serial or model codes
- Lot 097525, 097526, 532370 and 532810.
- 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