Z-1522-2018 Class II Terminated
FDA device recall Z-1522-2018 was initiated by Zimmer Biomet, Inc. on Apr 3, 2018 and is designated Class II. Reason for recall: There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar. The recall status is terminated (terminated Jul 2, 2018). Affected quantity: 16 units (21 distribution events. The product is lot controlled and may be distributed multiple times if it was returned…
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- Apr 3, 2018
- Termination Date
- Jul 2, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 units (21 distribution events. The product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf)
Product Description
Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.
Reason for Recall
There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar.
Distribution Pattern
The product was distributed to the following states: CT, FL, GA, IN, MA, MI, NY, and TX. The product was distributed to the following countries: Malaysia and Netherlands.
Code Information
Lot Number 360610, 333020
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1522-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026