FDA Recall 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.

Recall: Z-1064-2018 · Initiated December 7, 2017

Recall

Recall Number: Z-1064-2018
Event Number: 79387
Firm: Zimmer Biomet, Inc.
FEI Number: 1825034
Product Code: HWC
Status: Terminated
Root Cause: Error in labeling
Initiated: December 7, 2017
Terminated: April 17, 2020
Address: 56 E Bell Dr, Warsaw, IN, 46582-6989

Description

Reason

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

Action

Zimmer Biomet sent an Urgent Medical Device Recall letter dated December 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Review this notification n and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form and send to [email protected] within three (3) days. b. Request an International Return Authorization Number by emailing [email protected] c. For each return, send a copy of Attachment 1 to [email protected]. d. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. e. Mark "RECALL" on the outside of the returned cartons. 4. Return a copy of the your Inventory Return Certification and product return form. 5. For questions call customer service at 574-374-3071.

Distribution

Canada.

Quantity