GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product Code 1020-18. Intended for use in women as a suburethral sling
FDA device recall Z-0268-2010 · posted 2009-11-16 · Terminated
Recall details
- Recalling firm
- Generic Medical Devices
- Reason for recall
- Product that is approved only for use outside the U.S. was shipped to two customers in the U.S.
- Action taken
- On June 17, 2009 the recalling firm called the consignees and arranged for the unused product to be returned. On July 13, 2009 the firm sent a notification letter to the consignee that had implanted 1 of the devices.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 15 devices
- Distribution
- USA - NJ, and PA
- Date initiated
- 2009-06-18
- Date posted
- 2009-11-16
- Date terminated
- 2012-03-14
- Location
- Gig Harbor, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 (K083471) | Generic Medical Device, Inc. | 2009-03-03 |