Orthopedic Plates Recalled Due to Incorrect Etching and Mislabeling
One lot of DVR Anatomic distal radius orthopedic plates was incorrectly etched during manufacturing and may have been placed into kits labeled as a different plate model. The affected plates were distributed to healthcare facilities nationwide.
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 3/5 (High).
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: FDA Class II recall for manufacturing defect (incorrect etching) and potential mislabeling of orthopedic implant plates. No illnesses or injuries reported. Meets the High severity criterion for risk-of-harm products where actual injury has not yet been reported.
Plain-English summary
DVR Anatomic distal radius orthopedic plates are being recalled due to a manufacturing error. One lot of plates (lot J7014671) was incorrectly etched and may have been placed into kits labeled as a different plate model than intended.
The affected lot was distributed nationwide to healthcare facilities in the following states: Alabama, California, Colorado, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Maine, Minnesota, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New York, Tennessee, Virginia, Washington, and Wisconsin.
These surgical implant plates are used by orthopedic surgeons for the fixation of fractures and osteotomies involving the distal radius bone. Because the plates were incorrectly etched and potentially mislabeled in their distribution kits, they may not have been used for their intended purposes.
Healthcare providers should contact CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. regarding the affected lot and any necessary corrective actions. Patients with these implants should consult their healthcare provider if they have concerns.
The recalled product
- Product
- DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.
- Manufacturer
- CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.
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)
- UDI: (01)00887868070853 (11)210429(10)J7014671 Lot J7014671
Distribution
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