Recalls / —
—#173365
Product
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 product code
- HXX — Screwdriver
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Lot Numbers: 235471 235472 235473 235474 235475 187762 193492 193493 193494 193495 193496 193565 BF10LBJ BFI0LBJ BFI0M9E BFI0N10 BFI0N11 BFI0P39 I0N0X I0N0XR I0N0Y I0N10 I0N11 I0N5B I0P39 225207 BFIOLBJ I0N5P
Why it was recalled
There is a potential for weak seals of the sterile packaging.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Zimmer Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582-6989
Distribution
- 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.
Timeline
- Recall initiated
- 2019-05-28
- Terminated
- 2021-11-19
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #173365. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.