Z-2965-2018 Class II Terminated
FDA device recall Z-2965-2018 was initiated by Zimmer Biomet, Inc. on Jul 12, 2018 and is designated Class II. Reason for recall: A size 22mm threaded peg was found in the package of a 10mm unit. The recall status is terminated (terminated May 1, 2020). Affected quantity: 25 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 12, 2018
- Initiation Date
- Jul 12, 2018
- Termination Date
- May 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 units
Product Description
Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.
Reason for Recall
A size 22mm threaded peg was found in the package of a 10mm unit.
Distribution Pattern
International Distribution to countries of: Japan and Netherlands.
Code Information
Lot 969440; UDI (01)00887868012310(17)280309(10)969440
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2965-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026