FDA recall Z-0581-2025

Product

BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

Reason for recall

Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

Distribution

Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR.

Key facts

Status

Ongoing

Initiation date

2024-10-29

Report date

2024-12-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0581-2025