The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is intended for single patient use only

FDA device recall Z-1390-2011 · posted 2011-02-22 · Terminated

Recall details

Recalling firm

Generic Medical Devices

Reason for recall

Protective sheath sticks to itself and sleeve breakage has resulted in complaints and MDRs.

Action taken

The firm, GMD, issued an "URGENT MEDICAL DEVICE RECALL" letter dated February 14, 2011 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed not to use any GMD Model 1010 Universal Slings remaining in their inventory; return any Model 1010 slings in their possession to the Distributors or GMD; notify their customers to whom they shipped Model 1010s of this voluntary recall and request them to return any Model 1010 slings in their possession to them; and return all Model 1010 inventories to GMD using the attached Recalled Model 1010 Return Form. Note: Full credit in the amount of the returned products purchase price will be issued for all sterile, unexpired product returned to GMD. Contact the GMD Product Performance Senior Manager, at phone: (253) 853 3512 or email: 1010recall@gmd-us.com, if you have any questions/issues related to this recall.

Root cause

Component design/selection

Status

Terminated

Product code

FTL

Quantity affected

approximately 1711

Distribution

Worldwide distribution: USA and countries including: Australia, Argentina, Brazil, Canada, South Africa, and Scandinavia.

Date initiated

2011-02-14

Date posted

2011-02-22

Date terminated

2012-09-24

Location

Gig Harbor, WA

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