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U.S. Department of Health and Human Services

Class 2 Device Recall 4.0mm X 20mm Cancellous Screw; 4.0mm X 22mm Fully Threaded Screw

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  Class 2 Device Recall 4.0mm X 20mm Cancellous Screw; 4.0mm X 22mm Fully Threaded Screw see related information
Date Initiated by Firm June 12, 2014
Date Posted July 10, 2014
Recall Status1 Terminated 3 on June 24, 2015
Recall Number Z-2032-2014
Recall Event ID 68547
510(K)Number K934765  
Product Classification Screw, fixation, bone - Product Code HWC
Product Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing process.
Code Information Lot No. 62629432 Lot No. 62628759
Recalling Firm/
Zimmer Manufacturing B.V.
Turpeaux Industrial Park Rd 1 km 123.4
Mercedita PR 00715
Manufacturer Reason
for Recall
Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14.
FDA Determined
Cause 2
Process design
Action Zimmer sent an Urgent Medical Device Recall Lot specific letter dated June 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: 1. Please locate, quarantine, and return the affected product (part number 00-4840-020-00 lot number 62629432 and part number 00-2347-022-14 lot number 62628759) from all inventories. 2. Please note that any hospitals that received direct shipments of this product from Zimmer will be notified via Fed Ex. 3. Please review the list of hospital and surgeons to be provided to your territory via email. 4. Provide the name, address, and phone number of any additional hospitals or surgeons that may have received or used the affected product, or confirm that the list provided is complete. 5. Complete and return Attachment 1. 6. Ensure that a copy of the Risk Managers and Surgeons letter is left with the facilities from which product is removed by providing them with a copy of the letter, if they are not identified as a facility receiving a letter directly from Zimmer. 7. If after reviewing this notification you have questions or concerns, please contact Zimmer at 1-877-946-2761.
Quantity in Commerce 496
Distribution Worldwide Distribution - USA (nationwide) and the countries of India, Japan, China, Australia and 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 = ZIMMER, INC.