ClearanceBrief
Recall Z-0866-2007 ยท LXH Orthopedic Manual Surgical Instrument

Smith & Nephew Inc

Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 60 mm cup Ref.: 74120160

DateJun 7, 2007 (initiated Mar 13, 2007)
StatusTerminated
ReasonThe carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.
Root causeOther
ActionThe consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.
Quantity1 unit
DistributionEurope. No domestic distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.