Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
Reported: August 29, 2018 Initiated: June 22, 2018 #Z-2876-2018
Product Description
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
Reason for Recall
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.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 385
- Distribution
- Worldwide Distribution - Nationwide distribution and the countries of Japan and Netherlands.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures. Recalled by Zimmer Biomet, Inc.. Units affected: 385.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 29, 2018. Severity: Moderate. Recall number: Z-2876-2018.
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