Recall Z-1240-2018 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Biomet, Inc.
Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery
| Date | Oct 24, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| Action | The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 10/31/2017 to customers titled "Affected Product: Persona Partial Knee Spacer Blocks Size 8mm, 9mm, 10mm, 12mm, 14mm". The letter described the product, problem, and actions to be taken. The letter instructed customers to review the notification and ensure that affected personnel are aware of the contents. Review inventory for affected product which would then be quarantined and ultimately removed by a firm sales representative. The customers were also instructed to complete and return the Certificate of Acknowledgem |
| Quantity | 430 |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.