Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls 6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product U…

Recall date
December 7, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1064-2018
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

Get recall alerts

Free email alert whenever Zimmer Biomet, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Zimmer Biomet, Inc.