Zimmer Gmbh: Medical Device Recall in 2016 - (Recall #: Z-2321-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 27, 2016

Date Posted: August 10, 2016

Recall Number: Z-2321-2016

Event ID: 74548

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.

Status: Terminated

Product Quantity: 169

Code Information:

Part No.: 502015621; Lot Numbers: 8695/188B11, 8916/188B11, 9555/188D11, 10413/311A12, 11137/188B12

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

Voluntary or Mandated:

Voluntary: Firm initiated