Recall Z-1220-2026— Miach Orthopaedics
Class II · Ongoing
Class II FDA medical device recall by Miach Orthopaedics, initiated 2025-12-31. It names one FDA 510(k) clearance: K243578. Product: BEAR Implant. Model Number: 1000.. 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..
- Recalling firm
- Miach Orthopaedics
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-12-31
- Firm location
- Westborough, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
BEAR Implant. Model Number: 1000.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.