Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number
FDA device recall Z-1697-2014 · posted 2014-06-02 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corporation
- Reason for recall
- New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfix screws in Lot no. F626 (Catalogue No. 285322S) have been packaged and labeled as 3.5mm Diameter x 30 mm Length Surfix screws (Catalogue No. 285330S).
- Action taken
- Integra issued an Urgent Voluntary Medical Device Recall letter dated March 28, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for affected product, immediately stopo using or distributing them. Customers were asked to complete the Acknowledgement Form and return by email or fax as indicated on the form. When the form is received customer service will contact customers to provide an RMA number and directions to return the affected products. Customers with questions were instructed to call 1-855-532-1723. For questions regarding this recall call 609-275-2700.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 417 units
- Distribution
- Worldwide Distribution - USA including AR, CA, NC, TX and Internationally to Austria, Chile, Denmark, Finland, France, Germany, Greece, Ireland, Italy ,Lebanon, Portugal, Russia, South Africa, Spain,
- Date initiated
- 2014-03-28
- Date posted
- 2014-06-02
- Date terminated
- 2016-04-18
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEWDEAL TIBIAXYS SYSTEM (K073375) | Newdeal Sas | 2008-02-21 |