Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1514-06

Smith & Nephew Hip Positioning System Ref: 72200624 with System Components: Perineal Post 72200631 Universal...

Smith & Nephew, Inc. / initiated 2006-05-22 / Terminated

Smith & Nephew, Inc. Endoscopy Division began a recall of Smith & Nephew Hip Positioning System Ref: 72200624 with System Components: Perineal Post 72200631 Universal Hip Distractor 72200626 Knee Holder 72200627 Well... on . The reason FDA records is "The Perineal Post may crack or break and the Universal Hip Distractor (carriage) may not maintain adequate traction for the duration of the procedure". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1514-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Smith & Nephew, Inc.
Product
Smith & Nephew Hip Positioning System Ref: 72200624 with System Components: Perineal Post 72200631 Universal Hip Distractor 72200626 Knee Holder 72200627 Well Leg Holder 72200632 Supine Table Extension 72200629
Product code
JEB Table, Surgical With Orthopedic Accessories, Manual
Reason for recall
The Perineal Post may crack or break and the Universal Hip Distractor (carriage) may not maintain adequate traction for the duration of the procedure
FDA root cause
Other
Action
Smith & Nephew notified accounts on 5/22/06 by Letter via Federal Express to User Facility and Sales Reps and follow up telephone call to the user facilities. Devices are requested to be returned.
Quantity in commerce
3
Distribution
Nationwide distribution ---- including states of NM, MO, and TN.
Product codes and lots
Product distributed prior to May 5, 2006