Locking Cortical Screw recallZ-0716-2014 · Biomet, Inc. · initiated Dec 19, 2013
Class II Terminated All recalls posted in January 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling mix-ups
What the company is doing
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.
Recall details
- Recall number
- Z-0716-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 19, 2013
- Posted by the FDA
- Jan 10, 2014
- Recalling firm
- Biomet, Inc.
- Quantity
- 52
- Product code
- HRS
- FDA submissions
- K072083, K072832, K082300
- Distribution
- US Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA.
Product description
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Code information (models, lots, serial numbers)
Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D
Other devices under the same FDA submission
1 device cleared under K072083, K072832, K082300 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- A.L.P.S.® 8513-18-500Biomet Orthopedics, LLC · Plate, fixation, bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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