Terminated

DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.

FDA Recall Z-1946-2019 · Posted None

Recalling FirmZimmer Biomet, Inc.

Recall StatusTerminated

Product CodeHXX

Date Initiated2019-05-28

Date Terminated2021-11-19

Product Quantity3022 total

Reason for Recall

There is a potential for weak seals of the sterile packaging.

Firm Action

Urgent Medical Device Recall notification letters dated 5/28/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - US Nationwide: AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH OK, OR, PA, SC, TN, TX, UT, WA, WI, WV, and Puerto Rico. Products were distributed to the following foreign countries: Australia, Canada, Chile, Japan, Netherlands.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.