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Recall Observatory FDA recall evidence

Device product

Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery

Z-1240-2018

October 24, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 79395
Status
Terminated
Classification
Class II
Quantity
430
Official record key
device-enforcement:Z-1240-2018

Official wording

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.

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

Distribution pattern: US Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.