Z-0708-03

DeRoyal''s SurgiMate (tm) Skin Stapler, Rotating Head, product #25-1001, packaged with 35 or more stainless...

Name: Z-0708-03 DeRoyal''s SurgiMate (tm) Skin Stapler, Rotating Head, product #25-1001, packaged with 35 or more stainless...
Creator: Deroyal Surgical -Rose Hill
Published: 2003-02-25
License: https://open.fda.gov/license/

Deroyal Surgical -Rose Hill / initiated 2003-02-25 / Terminated / root cause: labeling and UDI

FDA source

Deroyal Surgical -Rose Hill began a recall of DeRoyal''s SurgiMate (tm) Skin Stapler, Rotating Head, product #25-1001, packaged with 35 or more stainless steel staples in peel away pouch. Pouch is labeled... on 2003-02-25. The reason FDA records is "Non-sterile surgical medical device is labeled as sterile product". 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-0708-03
Status: Terminated
Initiated: 2003-02-25
Posted: 2003-04-03
Terminated: 2003-07-07
Recalling firm: Deroyal Surgical -Rose Hill
Product: DeRoyal''s SurgiMate (tm) Skin Stapler, Rotating Head, product #25-1001, packaged with 35 or more stainless steel staples in peel away pouch. Pouch is labeled in part, ***sterile, disposable, do not resterilize***. Pouches are packaged 12 per box.
Product code: MNV Strip, Dialysate Ph Indicator
Reason for recall: Non-sterile surgical medical device is labeled as sterile product.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Recalling firm notified consignees by certified mail 2/25/03 and advised to immediately cease using or distributing product. Distributors were requested to further notify their consignees or provide customer contacts. Consignees requested to return response form for replacement product.
Quantity in commerce: 216 units
Distribution: Product was sold to distributors and direct accounts in PA, TX, WA, AR, HI, CA and TN.
Product codes and lots: Finished device lot numbers 502974, 505303, on outside of box. Individual pouches labeled with ''raw'' lot number NH030123-1.

Product code MNV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

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)