Custom surgical kits: DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries

FDA device recall Z-1003-2012 · posted 2012-02-13 · Terminated

Recall details

Recalling firm

DeRoyal Processing Center

Reason for recall

The firm distributed surgical kits which contained DermaHook Neuro Elastic Retractors which were subsequently recalled by Teleflex.

Action taken

DeRoyal Industries sent a Customer letter dated January 6, 2012, to the affected customer. The letter identified the product the problem and the action needed to be taken by the customer. An email was also sent on January 10, 2012, to the affected customer. The customer was requested to follow these instructions. 1) Identify any affected inventory using the product and lot numbers on Attachment 1. 2) Attach the provided warning label to each affected kit and tray. 3) Forward this recall to any of your end users that may have affected product. 4) Complete and return Attachment 1 by fax (865-362-3716) or email (recalls@deroyal.com) within two weeks of the date of this letter, even if you no longer have affected inventory. If you have questions or need assistance with the recall, including additional labels, please call (865) 362-1037 . We apologize for any inconvenience this may caused you.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LRP

Quantity affected

214 units

Distribution

(USA) including Indiana

Date initiated

2012-01-10

Date posted

2012-02-13

Date terminated

2012-11-05

Location

New Tazewell, TN