Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in I
FDA device recall Z-1448-2014 · posted 2014-04-10 · Terminated
Recall details
- Recalling firm
- Pega Medical Inc.
- Reason for recall
- The Male Components in this lot are made of material with lower strength than manufacturing specifications.
- Action taken
- Pega Medical sent an Urgent Field Safety Notice-Recall letter dated February 7, 2014, to their customers via email. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to identify the affected devicee, verify if it was used in a patient and place the affected device in quarantine immediately if not used. If not used, return the affected device to Pega Medical Inc. to the address provided. Pega's customer notification stated "If used, it is recommended to continue the normal patient follow up. Customers with questions should call (450) 688-5144 ext. 242 or email egarcia@pegamedical.com
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- Total of 5 units (2 units in the US and 3 units in Germany)
- Distribution
- Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.
- Date initiated
- 2014-02-07
- Date posted
- 2014-04-10
- Date terminated
- 2014-04-23
- 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 |