Recall Z-1946-2019 ยท HXX Screwdriver
Zimmer Biomet, Inc.
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.
| Date | May 28, 2019 |
| Status | Terminated |
| Reason | There is a potential for weak seals of the sterile packaging. |
| Root cause | Under Investigation by 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. |
| Quantity | 3022 total |
| Distribution | 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, Netherland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.