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
FDA Recall Z-1514-06 · Posted 2006-09-30
Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeJEB
Date Initiated2006-05-22
Date Terminated2012-05-09
Product Quantity3
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
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide distribution ---- including states of NM, MO, and TN.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.