FDA recall Z-1240-2018

Product

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

US Nationwide Distribution.

Key facts

Status

Terminated

Initiation date

2017-10-24

Report date

2018-04-04

Termination date

2019-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1240-2018