Z-1946-2019Class II

DVR Crosslock ePAK Screw Driver, Model Number 212000002

Name: Z-1946-2019 DVR Crosslock ePAK Screw Driver, Model Number 212000002
Creator: Zimmer Biomet, Inc.
Published: 2019-05-28
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2019-05-28 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of... on 2019-05-28. FDA classified it as Class II and gives the reason as "There is a potential for weak seals of the sterile packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1946-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-28
Posted: 2019-07-04
Terminated: 2021-11-19
Recalling firm: Zimmer GmbH
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.
Product code: HXX Screwdriver
Reason for recall: There is a potential for weak seals of the sterile packaging.
Root cause tag: packaging
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1946-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1946-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-04
Z-1947-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-04
Z-1948-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-04

Product code HXX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)