Z-0948-03

StayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by Zimmer

Name: Z-0948-03 StayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by Zimmer
Creator: Pioneer Surgical Technology
Published: 2003-05-28
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2003-05-28 / Terminated / root cause: labeling and UDI

FDA source

Pioneer Surgical Technology began a recall of StayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by Zimmer on 2003-05-28. The reason FDA records is "Label may bear an incorrect part number [2227-02-02] and size [03.8MM]". 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-0948-03
Status: Terminated
Initiated: 2003-05-28
Posted: 2003-06-21
Terminated: 2003-09-12
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product: StayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by Zimmer
Product code: HWC Screw, Fixation, Bone
Reason for recall: Label may bear an incorrect part number [2227-02-02] and size [03.8MM].
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A recall letter dated 5/28/03 was sent to the sole distributor, asking them to recall from their customers.
Quantity in commerce: 159
Distribution: Indiana
Product codes and lots: lot 77091367.

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)