Z-2289-2018 Class II Terminated
FDA device recall Z-2289-2018 was initiated by Zimmer Biomet, Inc. on May 24, 2018 and is designated Class II. Reason for recall: Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of… The recall status is terminated (terminated Apr 7, 2020). Affected quantity: 48.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 4, 2018
- Initiation Date
- May 24, 2018
- Termination Date
- Apr 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48
Product Description
Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthroplasties.
Reason for Recall
Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant.
Distribution Pattern
Distributed to accounts in CA, CT, GA, IA, IN, LA, MA, MD, MN, MS, NJ, OH, PA, TN, TX, UT, VA, WI. Foreign distribution to Taiwan, Japan, and the Netherlands.
Code Information
Lots 198810 and 210320
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2289-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026