| Class 3 Device Recall Smith & Nephew, Well Leg Holder | |
Date Initiated by Firm | November 01, 2006 |
Date Posted | June 06, 2007 |
Recall Status1 |
Terminated 3 on June 16, 2008 |
Recall Number | Z-0872-2007 |
Recall Event ID |
37792 |
Product Classification |
Well Leg Holder (Arthroscopic Accessory) - Product Code NBH
|
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. |
Code Information |
Serial #s: 286092, 287285, 287287, 287288, 287289, 287290, 287291, 289740, 289743, 290456, 290457 and 290837. |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc Endoscopy Division 76 S. Meridian Ave Oklahoma City OK 73107-6512
|
Manufacturer Reason for Recall | The device was not manufactured to correct specification causing interference when used in conjunction with Patient Transfer Board. |
FDA Determined Cause 2 | 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 |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|