Z-2323-2016Class II

V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot...

Name: Z-2323-2016 V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot...
Creator: Zimmer Gmbh
Published: 2016-06-27
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-06-27 / Terminated

FDA source

Zimmer Gmbh began a recall of 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 on 2016-06-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2323-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-27
Posted: 2016-08-02
Terminated: 2017-05-30
Recalling firm: Zimmer GmbH
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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 root 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
Product codes and lots: Part No.: 502015635; Lot Numbers:9721/188D11

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2323-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2321-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-02
Z-2322-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-02
Z-2323-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-02
Z-2324-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-02

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)