Biomet DVR Crosslock Screws Recalled Due to Incorrect Length Labeling
Zimmer Biomet is recalling two lots of Biomet DVR Crosslock Screws because the actual screw lengths do not match the labels.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk-of-harm product (orthopedic screws) where the physical dimensions do not match the label, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling two lots of Biomet DVR Crosslock Screws. The recall involves Lot 029970, labeled as 2.7mm x18mm, which contains 20mm locking screws, and Lot 029980, labeled as 2.7mm x 20mm, which contains 18mm locking screws.
The FDA has classified this as a Class II recall. 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 distribution pattern for the recalled product is listed as the Country of Japan. No specific injury or illness reports are mentioned in the source text.
The recalled product
- Product
- Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: 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 th
- Manufacturer
- Zimmer Biomet, Inc.
- 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 029970 UDI (01)00880304535572(17)280501(10)029970
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.
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