Recall StatusTerminated
Date Initiated2016-06-27
Date Terminated2017-05-30
Product Quantity169
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.
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
Root Cause
Under Investigation by firm
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.