Z-3254-2011

Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray, REF 50-5613, 1 Per...

Name: Z-3254-2011 Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray, REF 50-5613, 1 Per...
Creator: Deroyal Industries, Inc. Lafollette
Published: 2011-05-05
License: https://open.fda.gov/license/

Deroyal Industries, Inc. Lafollette / initiated 2011-05-05 / Terminated / root cause: design

FDA source

Deroyal Industries, Inc. Lafollette began a recall of Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray, REF 50-5613, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal... on 2011-05-05. The reason FDA records is "The firm distributed surgical kits which contained circumcision clamps that were subsequently recalled by Surgical Design". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3254-2011
Status: Terminated
Initiated: 2011-05-05
Posted: 2011-09-16
Terminated: 2013-01-30
Recalling firm: Deroyal Industries, Inc. Lafollette
Product: Circumcision trays and packs listed as follows: (1) DeRoyal (R) ST. Circumcision Tray, REF 50-5613, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Made in Dominican Republic Lot Numbers: 20854003, 22892644 (2) DeRoyal (R) ST. Circumcision PACK 1.3 CLAMP CLAMPMEMORIAL HEALTH, MEMORIAL HOSP TAL WEST, REF 89-5699, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Number 20012949 Circumcision Clamp
Product code: HFX Clamp, Circumcision
Reason for recall: The firm distributed surgical kits which contained circumcision clamps that were subsequently recalled by Surgical Design.
Root cause tag: design
FDA root cause: Other
Action: DeRoyal Industries, Inc. sent a recall notification letter dated 05/05/2011. A second notice was sent on 07/26/2011 to affected customers who did not respond to the initial notice. Questions regarding this recall may contact the Corporate Attorney at (865) 362-1037.
Quantity in commerce: 390 units
Distribution: USA (nationwide) including the states of AR, AZ, FL, GA, LA, MI, NJ, NM, and OH.
Product codes and lots: Lot Numbers: 20854003, 22892644, and 20012949

Product code HFX

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)