PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: March 21, 2018 Initiated: December 7, 2017 #Z-1064-2018

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.

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
6
Distribution
Canada.
Location
Warsaw, IN

Frequently Asked Questions

What product 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.. Recalled by Zimmer Biomet, Inc.. Units affected: 6.
Why was this product recalled? ▼
One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 21, 2018. Severity: Moderate. Recall number: Z-1064-2018.

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