FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Ringloc + Acetabular Shell limited hole, 60 mm Size 25, porous coat, for uncemented use, sterile, REF 16-116060, Biomet Orthopedics, Warsaw, IN.
- Recall number
- Z-2440-2011
- Recalling firm
- Biomet, Inc.
- Product
- Ringloc + Acetabular Shell limited hole, 60 mm Size 25, porous coat, for uncemented use, sterile, REF 16-116060, Biomet Orthopedics, Warsaw, IN.
- Status
- Terminated
- Initiated
- 2011-04-14
- Posted
- 2011-06-08
- Terminated
- 2011-09-16
- Reason
- The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
- Root cause
- Employee error
- Action
- Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Immediately locate and remove the affected product. Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product. Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756. For any questions regarding this recall call 574-371-3755 or 574-371-3756.
- Quantity
- 23
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
- Lot, serial or model codes
- Lot numbers M510810, M510820 and M845540.
- 510(k) numbers
- ["K093235"]
- PMA numbers
- not on file
- Product code
- KWA
- 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
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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