Integra Newdeal SURFIX Fixed Angle Locking Screw 3 — Class II medical device recall Z-1697-2014
Terminated recall by Integra LifeSciences Corporation, reported 2014-06-11, distributed in AR, CA, NC, TX. New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfix screws in L
| Recall number | Z-1697-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corporation, Plainsboro, NJ, United States |
| Recall initiated | 2014-03-28 |
| Classified | 2014-06-02 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2016-04-18 |
| Distributed | AR, CA, NC, TX |
| Countries outside the US | AE, AT, CH, CL, DE, DK, ES, FI, FR, GB, GR, IE, IT, LB, PT, RU, ZA |
| Quantity | 417 units |
| Reason classes | labeling |
| Lot numbers | F6S6, F6ZL |
| Model numbers | 285322S, 285330S |
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.
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1697-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.