FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1946-2019
- Recalling firm
- Zimmer Biomet, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2019-05-28
- Posted
- not on file
- Terminated
- 2021-11-19
- 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, Netherlands.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HXX
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28