Biomet DVR Crosslock Screws Recalled for Incorrect Length Labeling
Zimmer Biomet is recalling two lots of Biomet DVR Crosslock Screws because the physical screw lengths do not match the labels.
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. The hazard is a labeling error where the physical product does not match the label, which is a moderate risk but does not meet the criteria for Severe (Class II with hospitalization) or Critical (Class I).
Plain-English summary
Zimmer Biomet, Inc. is recalling two lots of Biomet DVR Crosslock Screws due to a labeling discrepancy. The product is intended for the stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones in the hand, foot, radius, ulna, ankle, humerus, scapula, and pelvis.
The recall involves Lot 029970, which is labeled as 2.7mm x 18mm but contains 20mm locking screws, and Lot 029980, which is labeled as 2.7mm x 20mm but contains 18mm locking screws. The source text indicates that the product was distributed in the country of Japan.
No specific instructions for consumers or healthcare providers are provided in the source text. The recall is driven by the mismatch between the labeled dimensions and the actual dimensions of the medical devices.
The recalled product
- Product
- Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 50
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- LOT 029980 UDI (01)00880304535589(17)280501(10)029980
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 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 2 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 · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateZimmer Biomet Recalls Mislabeled Periarticular Locking Plate System Screws
FDA (Devices) · 2016-01-20
- HighZimmer Biomet Recalls RingLoc Hip System Bone Screws Due to Packaging Error
FDA (Devices) · 2019-04-10
- ModerateZimmer EDI Periarticular Plating System Screws Recalled for Lot Commingling
FDA (Devices) · 2014-07-16
- ModerateZimmer Biomet Recalls Orthopedic Plates Due to Labeling Mismatch
FDA (Devices) · 2016-01-20
- HighSpinal fixation screws recalled due to incorrect size laser marking
FDA (Devices) · 2024-01-10
- HighBiomet Recalls Mislabelled 25mm Shoulder Prosthesis Central Screws
FDA (Devices) · 2021-02-24