Recall Z-3254-2011 ยท HFX Clamp, Circumcision
Deroyal Industries, Inc. Lafollette
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 O
| Date | Sep 16, 2011 (initiated May 5, 2011) |
| Status | Terminated |
| Reason | The firm distributed surgical kits which contained circumcision clamps that were subsequently recalled by Surgical Design. |
| 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 | 390 units |
| Distribution | USA (nationwide) including the states of AR, AZ, FL, GA, LA, MI, NJ, NM, and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.