Z-1240-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- October 24, 2017
- Termination Date
- April 3, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 430
Product Description
Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery
Reason for Recall
Zimmer Biomet is conducting a medical device recall for the Persona Partial Knee Spacer Blocks in sizes 8mm, 9mm, 10mm, 12mm, and 14mm. Complaints received indicated that flexion has the potential to feel tight during range-of-motion trialing and that the final trial has the potential to appear looser in extension.
Distribution Pattern
US Nationwide Distribution.
Code Information
42-5399-035-08/09/10/12/14 (Sizes 8mm, 9mm, 10mm, 12mm, 14mm) Lot numbers: 63552644 63579568 63547276 63579569 63610265 63549084 63579674 63594433 63610266 63549096 63579676 63594434 63610267 63549097 63579680 63596547 63613101