FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
- Recall number
- Z-0716-2014
- Recalling firm
- Biomet, Inc.
- Product
- Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
- Status
- Terminated
- Initiated
- 2013-12-19
- Posted
- 2014-01-10
- Terminated
- 2015-07-07
- Reason
- 3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.
- Root cause
- Labeling mix-ups
- Action
- URGENT MEDICAL DEVICE RECALL notices were sent to all consignees on December 19, 2013. Distributors who have affected hospitals in their regions were notified and provided with a copy of the notice that went to each hospital. Consignees are being contacted on an individual basis in an attempt to reconcile the product 100%. Fax back forms were provided to all consignees in order for Biomet to track returns. Non-responders will be contacted on an individual basis.
- Quantity
- 52
- Distribution
- US Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA.
- Lot, serial or model codes
- Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D
- 510(k) numbers
- ["K072083","K072832","K082300"]
- PMA numbers
- not on file
- Product code
- HRS
- 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