Grace Medical, Inc. recalls TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375…

Due to incorrect functional length on device labeling.

On 04/03/2026, the firm emailed a "RECALL NOTICE" to it single customer informing them that the firm determined the pistons were manufactured with an incorrect functional length. Devices are labeled as 3.75 mm but have an actual functional length of 4.00 mm. The customer was instructed to: " Immediately discontinue use and quarantine affected product " Return affected product using the provided RMA " If any devices have been used, provide the date(s) of surgery on the response form " Complete and return the enclosed Recall Response Form For questions - contact Grace Medical at 901-386-0990 or Thomas.fearnley@gracemedical.com.

• FDA enforcement recordOfficial FDA database entry for Z-2308-2026
• FDA 510(k) clearance · K060518The device's official FDA premarket clearance record
• FDA device classification · ETBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 874.3450The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Grace Medical, Inc.Search 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.