Z-2876-2018 Class II Terminated
FDA device recall Z-2876-2018 was initiated by Zimmer Biomet, Inc. on Jun 22, 2018 and is designated Class II. Reason for recall: The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was undersized, which could potentially lead to mating issues between the devices. This could cause a delay… The recall status is terminated (terminated Oct 9, 2019). Affected quantity: 385.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 29, 2018
- Initiation Date
- Jun 22, 2018
- Termination Date
- Oct 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 385
Product Description
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
Reason for Recall
The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was undersized, which could potentially lead to mating issues between the devices. This could cause a delay in surgery of less than 30 minutes. There is an option in the surgical technique for performing limb alignment without the alignment tower.
Distribution Pattern
Worldwide Distribution - Nationwide distribution and the countries of Japan and Netherlands.
Code Information
63465803, 63762260, 63767434, 63799794
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2876-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026