BEAR Implant. Model Number: 1000 recallZ-1220-2026 · Miach Orthopaedics · initiated Dec 31, 2025
Class II Open, Classified All recalls posted in January 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Miach Orthopaedics or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
FDA root cause category: Process control
What the company is doing
Notification to Sales Representatives and consignees began on about 12/31/2025 via email and letter titled URGENT MEDICAL DEVICE RECALL NOTIFICATION. Consignees were instructed to identify and quarantine all unused inventory of the affected lot, discontinue distribution of the affected lot, return all unused affected product, and complete and return the provided Recall Acknowledgement Form. Additionally, consignees were requested to notify customers if the affected lot was further distributed.
Recall details
- Recall number
- Z-1220-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Dec 31, 2025
- Posted by the FDA
- Jan 29, 2026
- Recalling firm
- Miach Orthopaedics
- Quantity
- 284 units
- Product code
- QNI
- FDA submissions
- K243578
- Distribution
- US Nationwide distribution in the states of AK, CA, CO, CT, FL, GA, IL, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, TX, VA, WA, WI.
Product description
BEAR Implant. Model Number: 1000.
Code information (models, lots, serial numbers)
Model Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BEAR Implant (Bridge-Enhanced ACL Restoration) 1000Miach Orthopaedics, Inc. · Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair2 recalls29 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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