FDA Medical Device Recalls (openFDA)
Biomet, Inc.: ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
- Recall number
- Z-1615-2014
- Recalling firm
- Biomet, Inc.
- Product
- ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
- Status
- Terminated
- Initiated
- 2014-04-22
- Posted
- 2014-05-13
- Terminated
- 2015-01-13
- Reason
- This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the set screw loosens, a revision surgery may be necessary.
- Root cause
- Process control
- Action
- Biomet sent an URGENT MEDICAL DEVICE SAFETY ALERT dated April 22, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
- Quantity
- 8 devices
- Distribution
- US Nationwide Distribution in the states of NY, MD, NC, SC, MI, OR, and NV.
- Lot, serial or model codes
- Catalog Number: 11-210062 Lot Number Identification: 972230
- 510(k) numbers
- ["K040611","K051385"]
- PMA numbers
- not on file
- Product code
- KWI
- 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