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U.S. Department of Health and Human Services

Class 2 Device Recall Cannulated Screw System

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  Class 2 Device Recall Cannulated Screw System see related information
Date Initiated by Firm December 07, 2017
Create Date March 15, 2018
Recall Status1 Terminated 3 on April 17, 2020
Recall Number Z-1064-2018
Recall Event ID 79387
510(K)Number K140891  
Product Classification Screw, fixation, bone - Product Code HWC
Product 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.
Code Information Lot: 120910
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.
FDA Determined
Cause 2		 Error in labeling
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 CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. Request an International Return Authorization Number by emailing zimmerbiometintlirarequests@zimmerbiomet.com c. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. 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.
Quantity in Commerce 6
Distribution Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = BIOMET, INC.
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