Westborough, MA, United States
Miach Orthopaedics recalls
2 recalls recorded since 2018, most recently on 31 December 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 31 December 2025
- Reason
- 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.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1220-2026
- BEAR Implant. Model Number: 1000.
Ongoing Class II Medical devices
- Recall started
- 2 February 2023
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0479-2026
- BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.