FDAClass IIApril 4, 2018

Persona recall

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

Why was Persona recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery
Recalling firm
Zimmer Biomet, Inc.
Quantity
430
Distribution
US Nationwide Distribution.
Recall date
April 4, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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