FDA-Device2026-02-04Class II
BEAR Implant. Model Number: 1000.
Miach Orthopaedics
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.
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-1220-2026Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief