BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Summary
The FDA issued a Class II for BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000; by Miach Orthopaedics. Reason: The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only..
Details
Source
Device Recall
External ID
Z-0479-2026
Action Date
2025-11-19
Status
Ongoing
Category
device
Product Description
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Lot/Code Info: Model/Catalog: 1000; UDI-DI: 00860002987804; Lot number: 7008409;
Quantity Affected: 167 units
Reason for Recall
The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-02
Company
Westborough, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 148 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Miach Orthopaedics has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Miach Orthopaedics) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Miach Orthopaedics have FDA actions?
Miach Orthopaedics has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0479-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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