Theken Companies LLC recalls iNSitu Bipolar Hip System

Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm

NextStep Arthropedix contacted their distributors via phone on September 11-12, 2025, to notify them of the situation. The distributors were instructed to quarantine and return all Bipolar Head implants. A formal recall letter with instructions for returning the inventory to NextStep Arthropedix was sent to customers on September 19, 2025.

• FDA enforcement recordOfficial FDA database entry for Z-0227-2026
• FDA 510(k) clearance · K191297The device's official FDA premarket clearance record
• FDA 510(k) clearance · K241875The device's official FDA premarket clearance record
• FDA device classification · MEHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3353The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Theken Companies 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.