TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and ha

FDA device recall Z-2321-2016 · posted 2016-08-02 · Terminated

Recall details

Recalling firm

Zimmer Gmbh

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.

Action taken

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

Root cause

Under Investigation by firm

Status

Terminated

Product code

LXH

Quantity affected

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

Date initiated

2016-06-27

Date posted

2016-08-02

Date terminated

2017-05-30

Location

Winterthur, Switzerland