FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.
- Recall number
- Z-1123-2015
- Recalling firm
- Biomet, Inc.
- Product
- Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.
- Status
- Terminated
- Initiated
- 2015-01-09
- Posted
- 2015-02-17
- Terminated
- 2015-10-22
- Reason
- Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.
- Root cause
- Packaging process control
- Action
- Biomet notified all domestic and foreign customers via FEDEx overnight on 1/9/2015. Response forms were provided, customers were instructed to notify hospital personnel if product was further distributed, and remove recalled products from circulation. Replacement parts were made available, customers may contact Audrey Daenzer, Field Action Specialist, Regulatory Compliance Biomet, Inc., audrev.daenzer@biomet.com, or 574-372-1570 Monday- Friday 8 AM to 5 PM.
- Quantity
- 17
- Distribution
- Distributed in the states of VA and TX and the country of Japan.
- Lot, serial or model codes
- Catalog Number: 16-104152 Lot Number Identification: 427840
- 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
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