FDA recall Z-0479-2026

Product

BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;

Reason for recall

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.

Key facts

Status

Ongoing

Initiation date

2023-02-02

Report date

2025-11-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Westborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0479-2026