Recall Z-1240-2018— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-10-24, terminated 2019-04-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery. Reason: 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..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-24
- Terminated
- 2019-04-03
- Firm location
- Warsaw, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.