Recalls / —

—#143033

Product

Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy.

FDA product code

NBH — Accessories, Arthroscopic

Device class

Class 1

Medical specialty

Orthopedic

Affected lot / code info

Lot Codes: ( Devices within Expiry) 3009063 3009559 3010117 3010720 3011688 3012095 3012366 3014560 3016455 3018390 3020194 3022929 3025736 3027818 3030178 3032892 3036529 3071312 3071546 3074279 3074280 3076377 3076427 3085969 3089220 3093258 3098516 3101929 3104300 3107341 3111387 3114657 3115976 3119607 3123832 3124356 3124896 3125448 3128384

Why it was recalled

Blade exhibiting fracture during hip arthroscopy procedures

Root cause (FDA determination)

Device Design

Action the firm took

Smith & Nephew issued letters via Federal Express on January 11, 2016. requested to inspect inventory and locate any unused devices and quarantine them immediately. Complete Inventory Return Certification Form on the following page, indicating the quantities that need to be returned. Contact Smith & Nephews Field Action Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to obtain a return authorization (RA) number.

Recalling firm

Firm

Smith & Nephew, Inc.

Address

150 Minuteman Rd, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern

Worldwide distribution. US Nationwide and countries of AT, AU, BE, CA, CH, CL, CN, CZ, DB, DE, DK, EE, ES, FI, FR, GB, HK, IE, IL, IN, IT, JP, LT, LV, NL, NO, PL, PR, PT, RO, SE, SG, SI, TH, TR, and ZA.

Timeline

Recall initiated

2016-01-11

Terminated

2017-09-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #143033. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.