Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedur

FDA device recall Z-0464-2013 · posted 2012-12-03 · Terminated

Recall details

Recalling firm

Merit Medical Systems, Inc.

Reason for recall

Custom Procedural trays contain Stryker Hytrel Togas which are being recalled because the clear tape that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.

Action taken

The firm, Merit Medical, sent an "URGENT PRODUCT RECALL NOTICE" letter dated June 8, 2012 to its customers by letter sent by US Postal Service - Certified Mail Receipt describing the problem, instructions as to actions that need to be taken, and requesting the customer to complete and sign the Customer Response Form and immediately fax a copy to this form to 1-804-416-1031. Customers were instructed to mail the completed original Customer Response Form using the provided postage-paid, self-addressed envelope to Merit. Should the customer choose to return the product for rework, they are to return the affected products by shipping them back to Merit Medical Systems via Federal Express 2nd Day Air (Acct #1129-5275-6) to: RGA Department RGA #NC-53417, Merit Medical Systems, Inc., Attn: Manager of Quality Assurance and Regulatory Affairs, 12701 Kingston Ave., Chester, VA 23836. For questions customers were instructed to contact Manager of Quality Assurance and Regulatory Affairs at 1-804-416-1048 or email: jbraxton@merit.com.

Root cause

Process control

Status

Terminated

Product code

LRO

Quantity affected

83 packs

Distribution

Nationwide distribution: US including states of: NE and SD.

Date initiated

2012-06-08

Date posted

2012-12-03

Date terminated

2012-12-10

Location

Chester, VA