Z-0561-04

Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001

Name: Z-0561-04 Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001
Creator: Pioneer Surgical Technology
Published: 2004-01-20
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2004-01-20 / Terminated / root cause: labeling and UDI

FDA source

Pioneer Surgical Technology began a recall of Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001 on 2004-01-20. The reason FDA records is "Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0561-04
Status: Terminated
Initiated: 2004-01-20
Posted: 2004-02-27
Terminated: 2004-05-20
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product: Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: 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.
Quantity in commerce: 318
Distribution: By Zimmer: Nationwide, Australia, Canada, Germany and United Kingdom.
Product codes and lots: Lot 77097300.

Product code HWC

K990804Class IIStayfusePioneer Surgical Technology / cleared 1999-04-29

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)