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OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacem...

FDA Recall #Z-1036-2023 — Class II — November 29, 2022

Recall #Z-1036-2023 Date: November 29, 2022 Classification: Class II Status: Ongoing

Product Description

OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602

Reason for Recall

Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement

Recalling Firm

Biomet, Inc. — Warsaw, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

2 units

Distribution

US Nationwide distribution in the states of CA, KY, FL.

Code Information

UDI: (01)00880304082991(17)321103(10)136620 Lot Number: 136620

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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