Z-1036-2023 Class II Ongoing
FDA device recall Z-1036-2023 was initiated by Biomet, Inc. on Nov 29, 2022 and is designated Class II. Reason for recall: Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement The recall status is ongoing. Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 8, 2023
- Initiation Date
- Nov 29, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602
Reason for Recall
Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
Distribution Pattern
US Nationwide distribution in the states of CA, KY, FL.
Code Information
UDI: (01)00880304082991(17)321103(10)136620 Lot Number: 136620
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1036-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026