Recall Z-2323-2016
Zimmer Gmbh · initiated June 27, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
Codes / lots: Part No.: 502015635; Lot Numbers:9721/188D11
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 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
Details
- Recall number
- Z-2323-2016
- Initiated
- June 27, 2016
- Posted by FDA
- August 2, 2016
- Terminated
- May 30, 2017
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Quantity
- 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…
- Recalling firm
- Zimmer Gmbh, Winterthur
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2321-2016 Class II | TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into…Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential… | 06/27/2016Terminated |
| Z-2322-2016 Class II | TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into…Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential… | 06/27/2016Terminated |
| Z-2324-2016 Class II | V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into…Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential… | 06/27/2016Terminated |