ACL restoration implants recalled from one lot held in sales stock
Miach Orthopaedics is recalling 167 BEAR Implants from a single lot, in an action the record says was limited to sales force trunk stock.
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: Scored 2 as a precautionary action: the record describes the scope of a limited field action without stating a defect or health consequence.
Plain-English summary
The BEAR Implant (Bridge-Enhanced ACL Restoration), model 1000, from Miach Orthopaedics, is being recalled.
The enforcement record states that the field action was initiated in February 2023 and was limited to the affected lot from sales force trunk stock only. It does not describe a device defect or a health consequence.
The recall covers 167 units carrying UDI-DI 00860002987804, from lot 7008409, distributed nationwide in the United States. The FDA has classified the action as Class II.
No injuries are reported. Facilities holding lot 7008409 should follow the firm's instructions.
The recalled product
- Product
- BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
- Manufacturer
- Miach Orthopaedics
- Hazard
- Affected units
- 167
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 (3)
- Model/Catalog: 1000
- UDI-DI: 00860002987804
- Lot number: 7008409
Distribution
Distributed nationwide across the United States.
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