Z-1697-2014Class II

Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm...

Name: Z-1697-2014 Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm...
Creator: Integra LifeSciences Corporation
Published: 2014-03-28
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2014-03-28 / Terminated / root cause: packaging

FDA source

Integra LifeSciences Corporation began a recall of Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in... on 2014-03-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1697-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-28
Posted: 2014-06-02
Terminated: 2016-04-18
Recalling firm: Integra LifeSciences Corporation
Product: Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone fractures or reconstruction of the ankle, foot or hand.
Product code: HWC Screw, Fixation, Bone
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).
Root cause tag: packaging
FDA root cause: Package design/selection
Action: 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.
Quantity in commerce: 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, Switzerland, United Arab Emirates, and United Kingdom.
Product codes and lots: SURFIX 3.5 mm D X 22 mm L /Cat No 285322S Lot no. F6S6; SURFIX 3.5 mm D X 30 mm L /Cat. No. 285330S Lot no. F6ZL

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1697-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1697-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02

Product code HWC

K073375Class IINewdeal Tibiaxys SystemNewdeal Sas / cleared 2008-02-21

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)