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U.S. Department of Health and Human Services

Class 2 Device Recall Circumcision trays and packs

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 Class 2 Device Recall Circumcision trays and packssee related information
Date Initiated by FirmMay 05, 2011
Date PostedSeptember 16, 2011
Recall Status1 Terminated 3 on January 30, 2013
Recall NumberZ-3254-2011
Recall Event ID 59770
Product Classification clamp, circumcision - Product Code HFX
ProductCircumcision 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
Code Information Lot Numbers: 20854003, 22892644, and 20012949  
FEI Number 3005011024
Recalling Firm/
Manufacturer		 Deroyal Industries, Inc. Lafollette
1501 East Central Ave
La Follette TN 37766-2892
For Additional Information ContactTracy Edmundson
865-362-2334
Manufacturer Reason
for Recall		The firm distributed surgical kits which contained circumcision clamps that were subsequently recalled by Surgical Design.
FDA Determined
Cause 2		Other
ActionDeRoyal 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 Commerce390 units
DistributionUSA (nationwide) including the states of AR, AZ, FL, GA, LA, MI, NJ, NM, and OH.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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