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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew

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  Class 2 Device Recall Smith & Nephew see related information
Date Initiated by Firm January 11, 2016
Create Date February 10, 2016
Recall Status1 Terminated 3 on September 18, 2017
Recall Number Z-0793-2016
Recall Event ID 73084
Product Classification Accessories,arthroscopic - Product Code NBH
Product Smith & Nephew BEAVER Blade 4.0mm
Part Number: 72203307
Orthopedic surgical instrument used in hip arthroscopy.
Code Information 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
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
150 Minuteman Rd
Andover MA 01810-1031
For Additional Information Contact SAME
978-749-1000
Manufacturer Reason
for Recall		 Blade exhibiting fracture during hip arthroscopy procedures
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 69043 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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