Well Leg Holder With Boot, part of the Supine Universal Hip Distractor System; Ref (Part) #72200632...
Smith & Nephew, Inc Endoscopy Division began a recall of Well Leg Holder With Boot, part of the Supine Universal Hip Distractor System; Ref (Part) #72200632; Manufactured for Smith & Nephew, Inc., Endoscopy Divsion... on . The reason FDA records is "The device was not manufactured to correct specification causing interference when used in conjunction with Patient Transfer Board". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0872-2007
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Smith & Nephew, Inc.
- Product
- Well Leg Holder With Boot, part of the Supine Universal Hip Distractor System; Ref (Part) #72200632; Manufactured for Smith & Nephew, Inc., Endoscopy Divsion, Andover, MA 01810.
- Product code
- NBH Accessories, Arthroscopic
- Reason for recall
- The device was not manufactured to correct specification causing interference when used in conjunction with Patient Transfer Board.
- Root cause tag
- manufacturing process
- FDA root cause
- Other
- Action
- Firm notified consignees by letter and phone call on 11/1/2006. Consignees asked to return out-of-spec Well Leg Holder for a replacement.
- Quantity in commerce
- 12
- Distribution
- Nationwide Distribution: USA including states of WI, CA, MO, IL, TX, MA, WA, NM, FL, NH, and SC and the UK
- Product codes and lots
- Serial #s: 286092, 287285, 287287, 287288, 287289, 287290, 287291, 289740, 289743, 290456, 290457 and 290837.
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