CLASS II ONGOING Device recall · Reported 19 Nov 2025 · FDA Enforcement Report
BEAR Implant (Bridge-Enhanced ACL Restoration) recalled
Miach Orthopaedics is recalling BEAR Implant (Bridge-Enhanced ACL Restoration), distributed nationwide in the US. The recall was initiated on 2 Feb 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0479-2026
- FDA event ID
- 97742
- Recalling firm
- Miach Orthopaedics, Westborough, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Feb 2023
- FDA classified
- 7 Nov 2025
- Reported
- 19 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 2 Feb 2023 | Recall initiated by company | |
| 7 Nov 2025 | Classified by FDA | +1009 days |
| 19 Nov 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is BEAR Implant (Bridge-Enhanced ACL Restoration) recalled?
Yes. Miach Orthopaedics recalled BEAR Implant (Bridge-Enhanced ACL Restoration) on 2 Feb 2023. The recall is Class II and its status is Ongoing. Recall number Z-0479-2026.
Why was it recalled?
The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
Which lots are affected?
Model/Catalog: 1000; UDI-DI: 00860002987804; Lot number: 7008409;
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Miach Orthopaedics
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BEAR Implant recalled by Miach Orthopaedics | Miach Orthopaedics | Other | Nationwide |
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