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6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421...

FDA Recall #Z-1064-2018 — Class II — December 7, 2017

Recall #Z-1064-2018 Date: December 7, 2017 Classification: Class II Status: Terminated

Product Description

6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product Usage: The 6.5/8.0mm Cannulated Screw System is part of a series of cannulated screws ranging from 4.0 to 8.0mm. Used in Slipped capital femoral epiphysis, Pediatric femoral neck fractures, Tibial plateau fractures, SI joint disruptions, Intercondylar femur fractures, Subtalar arthrodesis, and Fixation of pelvis and iliosacral joint.

Reason for Recall

One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.

Recalling Firm

Zimmer Biomet, Inc. — Warsaw, IN

Classification

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

Product Type

Devices

Product Quantity

6

Distribution

Canada.

Code Information

Lot: 120910

Status

Terminated

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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