ClearanceBrief
Recall Z-0793-2016 ยท NBH Accessories, Arthroscopic

Smith & Nephew, Inc.

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

DateJan 11, 2016
StatusTerminated
ReasonBlade exhibiting fracture during hip arthroscopy procedures
Root causeDevice Design
ActionSmith & 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.
Quantity69043 units
DistributionWorldwide 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.