Arrowhead DE LLC recalls Arrow-LOK Implant

Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.

On 6/23/2026 customers were phoned and informed to return affected implants. On 7/7/2026, recall notices were mailed to risk managers who were asked to do the following: 1) Cease use, distribution, and quarantine affected product. 2) Contact firm customer service to obtain instructions for returning product. 3) Email mail tracking numbers to firm. 4) Complete and return the acknowledgement and receipt form. Questions can be directed to the firm at 470-419-1429

• FDA enforcement recordOfficial FDA database entry for Z-2958-2026
• FDA 510(k) clearance · K112675The device's official FDA premarket clearance record
• FDA device classification · HTYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3040The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Arrowhead DE LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.