Persona recall
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
Why was Persona recalled?
The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was undersized, which could potentially lead to mating issues between the devices. This could cause a delay in surgery of less than 30 minutes. There is an option in the surgical technique for performing limb alignment without the alignment tower.
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?
63465803, 63762260, 63767434, 63799794
- Product
- Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 385
- Distribution
- Worldwide Distribution - Nationwide distribution and the countries of Japan and Netherlands.
- Recall date
- August 29, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)