Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orth
FDA device recall Z-1546-2015 · posted 2015-04-29 · Terminated
Recall details
- Recalling firm
- Pega Medical Inc.
- Reason for recall
- The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the instrument, possibly leading to deformation, wear, and tip breakage.
- Action taken
- The firm sent the Urgent Field Safety Notice-Recall letter, dated April 10, 2015 to consignees via email. The letter listed the affected product as FEMALE DRIVER FASSIER-DUVAL IM TELESCOPIC SYSTEM. Consignees are requested to return devices back to the firm for disposal. Consignees with questions should contact the firm at 450-688-5144 ext. 242 or send email to egarcia@pegamedical.com
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 9 units (5 units in the US and 4 units international)
- Distribution
- Worldwide distribution. US in Delaware, Florida, Nebraska, and New York; Australia, Brazil, and United Kingdom.
- Date initiated
- 2015-04-10
- Date posted
- 2015-04-29
- Date terminated
- 2015-06-29
- Location
- Laval, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FASSIER-DUVAL TELSCOPIC IM SYSTEM (K041393) | Pega Medical, Inc. | 2004-08-17 |
| FASSIRE-DUVAL TELESCOPIC IM SYSTEM (K020885) | Pega Medical, Inc. | 2003-02-06 |