Z-0793-2016Class II

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

Name: Z-0793-2016 Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy
Creator: Smith & Nephew, Inc.
Published: 2016-01-11
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2016-01-11 / Terminated / root cause: design

FDA source

Smith & Nephew, Inc. began a recall of Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy on 2016-01-11. FDA classified it as Class II and gives the reason as "Blade exhibiting fracture during hip arthroscopy procedures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0793-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-11
Posted: 2016-02-10
Terminated: 2017-09-18
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy.
Product code: NBH Accessories, Arthroscopic
Reason for recall: Blade exhibiting fracture during hip arthroscopy procedures
Root cause tag: design
FDA root cause: 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 [email protected] 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0793-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0793-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-10

Product code NBH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

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)