Z-0716-2014 Class II Terminated
FDA device recall Z-0716-2014 was initiated by Biomet, Inc. on Dec 19, 2013 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Jul 7, 2015). Affected quantity: 52.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 22, 2014
- Initiation Date
- Dec 19, 2013
- Termination Date
- Jul 7, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52
Product Description
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Reason for Recall
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.
Distribution Pattern
US Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA.
Code Information
Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0716-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026