FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc. Endoscopy Division: 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
- Recall number
- Z-1514-06
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- 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
- Status
- Terminated
- Initiated
- 2006-05-22
- Posted
- 2006-09-30
- Terminated
- 2012-05-09
- Reason
- The Perineal Post may crack or break and the Universal Hip Distractor (carriage) may not maintain adequate traction for the duration of the procedure
- 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
- 3
- Distribution
- Nationwide distribution ---- including states of NM, MO, and TN.
- Lot, serial or model codes
- Product distributed prior to May 5, 2006
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JEB
- Firm FEI
- 3003604053
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28