FDA-Device2026-02-04Class IIMISBRANDING
Miach Orthopaedics BEAR Implant Model 1000 recalled for incorrect expiration date
What this means
Miach Orthopaedics BEAR Implant Model 1000 units have an incorrect expiration date printed on the label that extends beyond the product's actual shelf life. Because the expiration date is wrong, the UDI (Unique Device Identifier) is also incorrect. This affects 284 units distributed nationwide.
- Check if you have BEAR Implant Model 1000, Lot Number 7011098, with expiration date 02/28/2026
- Do not use the implant if you have this lot number
- Contact your implant supplier or Miach Orthopaedics for replacement or guidance
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
284 units
Manufactured in
69 Milk St Ste 100, N/A, Westborough, MA, United States
Products
BEAR Implant. Model Number: 1000.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1220-2026Want us to check the next one for you?
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