Recall Z-1390-2011 ยท FTL Mesh, Surgical, Polymeric
Generic Medical Devices
The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is intended for single patient use only. The GMD Universal Sling is a sterile, single use device for the treatment of female stress urinary incontinence. It is comprised of a polypropylene sheath with a disposable universal low density polyethylene sleeve at each end of attachment of the sling to GMD's single use or
| Date | Feb 22, 2011 (initiated Feb 14, 2011) |
| Status | Terminated |
| Reason | Protective sheath sticks to itself and sleeve breakage has resulted in complaints and MDRs. |
| Root cause | Component design/selection |
| Action | 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 Recal |
| Quantity | approximately 1711 |
| Distribution | Worldwide distribution: USA and countries including: Australia, Argentina, Brazil, Canada, South Africa, and Scandinavia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083471 | GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 Generic Medical Device, Inc., Mar 3, 2009 |