FDAClass IIAugust 10, 2016

V-tek Twist D 40x90mm 30mm Cann 12mm Rnd recall

V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

Why was V-tek Twist D 40x90mm 30mm Cann 12mm Rnd recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part No.: 502015640; Lot Numbers:27374, 104547/188A9

Product
V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
Recalling firm
Zimmer Gmbh
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, Thailand, France, Israel, Jamaica, Japan, Jordan, Germany, Korea, Lebanon, Belgium, Hong Kong, Philippines, Iran, Brazil, Turkey, United Arab Emirates (UAE), Uruguay
Recall date
August 10, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls