The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1947-2019·Announced 2019-07-10

Zimmer Biomet Recalls DVR Crosslock ePAK Depth Gauges for Packaging Defects

Zimmer Biomet is recalling DVR Crosslock ePAK Depth Gauges due to a potential for weak seals in the sterile packaging.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states there is only a 'potential' for weak seals and does not report any illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling DVR Crosslock ePAK Depth Gauges, Model Number 212000003. These disposable instruments are used to facilitate the implantation of orthopedic medical devices in trauma settings.

The recall is being conducted because there is a potential for weak seals in the sterile packaging. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.

A total of 3,022 units were distributed worldwide, including across the United States and in Australia, Canada, Chile, Japan, and the Netherlands. The affected lot numbers are: 226646, 230493, 231877, 232682, 235476, BFI0LBKR, 187763, 193566, BF10LBK, BFA012345, BFI0LBK, BFI0M4H, BFI0M9F, BFI0N13, BFI0N14, BFION15, I0N12, I0N12R, I0N13, BF10M9F, and BFIOLBK.

The recalled product

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.
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Instrument
Hazard
Affected units
3,022

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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