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U.S. Department of Health and Human Services

Class 2 Device Recall DVR Crosslock ePAK Depth Gauge

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  Class 2 Device Recall DVR Crosslock ePAK Depth Gauge see related information
Date Initiated by Firm May 28, 2019
Create Date July 04, 2019
Recall Status1 Terminated 3 on November 19, 2021
Recall Number Z-1947-2019
Recall Event ID 83024
Product Classification Gauge, depth - Product Code HTJ
Product 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.
Code Information Lot Numbers: 226646 230493 231877 232682 235476 BFI0LBKR 187763 193566 BF10LBK BFA012345 BFI0LBK BFI0M4H BFI0M9F BFI0N13 BFI0N14 BFION15 I0N12 I0N12R I0N13 BF10M9F BFIOLBK 
Recalling Firm/
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
Manufacturer Reason
for Recall
There is a potential for weak seals of the sterile packaging.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.