Zimmer Biomet Recalls DVR Crosslock ePAK Screw Drivers Due to Packaging Seal Risk
Zimmer Biomet is recalling 3,022 DVR Crosslock ePAK Screw Drivers because sterile packaging seals may be weak, potentially compromising sterility.
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, and the hazard is a potential packaging defect (weak seals) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 3,022 units of the DVR Crosslock ePAK Screw Driver, Model Number 212000002. These disposable instruments are used to facilitate the implantation of orthopedic medical devices in trauma settings. The recall is due to a potential for weak seals in the sterile packaging.
The affected products were distributed worldwide, including nationwide in the United States and in Australia, Canada, Chile, Japan, and the Netherlands. Specific lot numbers are listed in the agency's recall record.
Consumers and healthcare facilities should stop using the affected products and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 3,022
Distribution
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 →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- HighBiomet Recalls Crosslock DVR ePAK Surgical Sets Due to Oxidation Risk
FDA (Devices) · 2016-03-16
- HighBIOMET Trauma DVR CROSSLOCK implants recalled for packaging integrity
FDA (Devices) · 2022-03-30
- ModerateZimmer Biomet Recalls Distal Lateral Femoral Locking Plates
FDA (Devices) · 2019-11-13
- HighBiomet DVR Crosslock Screws Recalled Due to Incorrect Length Labeling
FDA (Devices) · 2019-01-16
- ModerateBiomet DVR Crosslock Screws Recalled for Incorrect Length Labeling
FDA (Devices) · 2019-01-16
- HighZimmer Biomet Recalls Sterile Shoulder System Drills Due to Fracture Risk
FDA (Devices) · 2017-10-04