Pioneer Surgical Technology Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001.
Brand
Pioneer Surgical Technology
Lot Codes / Batch Numbers
Lot 77097300.
Products Sold
Lot 77097300.
Pioneer Surgical Technology is recalling Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001. due to Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.
Recommended Action
Per FDA guidance
Zimmer was notified of this recall via letter dated 1/20/04 requesting Zimmer to remove all of this lot from inventory and from point of use locations.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026