Zimmer Biomet recalls DVR Crosslock ePAK Screw Drivers with model 212000002 due to potential weak sterile packaging seals. Affected units include specific lot numbers from 2018-2023. Consumers should check their product for the model and lot numbers listed.
“Zimmer Biomet DVR Crosslock ePAK Screw Driver Recall: Weak Sterile Packaging Seals.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67841-zimmer-biomet-dvr-crosslock-epak-screw-driver-recall-weak-sterile. Based on FDA recall #Z-1946-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1946-2019%22&limit=1).
The FDA announced on May 28, 2019, that Zimmer Biomet, Inc. recalled DVR Crosslock ePAK Screw Drivers due to potential weak seals in sterile packaging. The agency classified the recall as Class II.
According to the FDA, there is a potential for weak seals of the sterile packaging associated with these DVR Express Disposable Instruments used to facilitate implantation of orthopedic medical devices in trauma.
Context
GovInfoNow's records show Zimmer Biomet, Inc. has 94 other recalls on record since June 5, 2017. Other recent recalls of similar products include Stryker Daig Livewire Steerable Catheter Recall (April 10, 2026), Medline Convenience Kits Recall (June 12, 2026), and Medline Forceps Recall (November 13, 2025).
How to tell if you have this one
Check for the model number 212000002 on the packaging. Affected units include specific lot numbers listed in the recall notice, such as 235471 through 235475 and others from 2018-2023.
Brand
Zimmer Biomet
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
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.
Recall number
Product, codes & lots
Z-1946-2019
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.; 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
Z-1947-2019
DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.; Lot Numbers: 226646 230493 231877 232682 235476 BFI0LBKR 187763 193566 BF10LBK BFA012345 BFI0LBK BFI0M4H BFI0M9F BFI0N13 BFI0N14 BFION15 I0N12 I0N12R I0N13 BF10M9F BFIOLBK
Z-1948-2019
K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.; Lot Numbers: 187764 193497 193567 232280 232683 232684 232685 232686 233858 234049 235477 BFI0LJ8 BFI0M5B BFI0MAV BFI0N16 BFI0NNN I0N17 I0N18 BFI0LJ8R BFI0MAVR BF10LJ8 BF10MAV BFIOLI8 I0NNN
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the model number 212000002 and lot numbers listed in the recall notice to confirm if your instrument is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 34 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1946-2019 (May 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1946-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.