Class 2 Device Recall TWIST DRILL Cannulated

• Date Initiated by Firm: June 27, 2016
• Date Posted: August 02, 2016
• Recall Status: Terminated on May 30, 2017
• Recall Number: Z-2321-2016
• Recall Event ID: 74548
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
• Code Information: Part No.: 502015621; Lot Numbers: 8695/188B11, 8916/188B11, 9555/188D11, 10413/311A12, 11137/188B12
• Recalling Firm/ Manufacturer: Zimmer Gmbh; Sulzer Allee 8; Winterthur Switzerland
• For Additional Information Contact: Kevin W. Escapule; 574-372-4487
• Manufacturer Reason for Recall: Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.
• FDA Determined Cause: Under Investigation by firm
• Action: Zimmer GmbH initiated a voluntary recall of the Normed - TWIST DRILL Cannulated & Normed- V-TEK TWIST DRILL Cannulated, with written notices on June 27, 2016 via certified mail due to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component. Customers are asked to do the following: Review the notification and ensure affected personnel are aware of the contents. 2. Locate all affected product identified above and quarantine them immediately. 3. Return any affected product within your possession. Clearly mark the outside of all return packages, Recall, and include a copy of the Inventory Return Certification form (Attachment 1) with your return shipment(s). 4. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. " Online:www.fda.gov/medwatch/report.htm " Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form. " Fax: 1-800-FDA-0178 Affected units returned as part of this recall activity will be scrapped
• Quantity in Commerce: 169
• Distribution: Domestic: CO, IL Foreign: Argentina, Costa Rica, India, Malta, Japan, Philippines, Vietnam, Portugal, Dominican Republic, Argentina, Australia, Russia, Saudi Arabia, Ireland, Ecuador, China, Singapore, Indonesia, Canada, Mexico, South Korea , Spain, Netherlands, Sweden, Malaysia, New Zealand, Switzerland, El Salvador, England, Norway, Finland, Venezuela, Taiwan, Italy, Colombia, Greece, Thailand, France, Israel, Jamaica, Japan, Jordan, Germany, Korea, Lebanon, Belgium, Hong Kong, Philippines, Iran, Brazil, Turkey, United Arab Emirates (UAE), Uruguay
• 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.