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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew

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 Class 2 Device Recall Smith & Nephewsee related information
Date Initiated by FirmOctober 10, 2003
Date PostedDecember 18, 2003
Recall Status1 Terminated 3 on January 28, 2016
Recall NumberZ-0247-04
Recall Event ID 27738
Product Classification Accessories, Photographic, For Endoscope (Exclude Light Sources) - Product Code FEM
ProductSmith & Nephew Endocoupler C-Mount 30mm Focal Length Reference: 7204823 and 7204823S (S indicates unit previously serviced)
Code Information Part Number: 7204823, Camera Coupler, C-Mount, 30mm F.L.  Serial Numbers (SR prefix):  8632 8646 8652 8659 8670 8679 8693 8709 8714 8633 8647 8655 8660 8675 8686 8694 8711 8716 8635 8648 8657 8665 8676 8687 8712 8727 8636 8649 8658 8668 8677 8691 8707 8713 8728  Part Number: 7204823S, Camera Coupler, C-Mount, 30mm F.L. Serial Number SR8705 
FEI Number 3003604053
Recalling Firm/
Manufacturer		 Smith And Nephew, Inc. Endoscopy Division
150 Minuteman Rd
Andover MA 01810-1031
For Additional Information ContactJason Bilobram
978-474-6332
Manufacturer Reason
for Recall		Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionSmith & Nephew notified direct accounts by letter on 10/15/03. Service representatives will remove and replace product.
Quantity in Commerce35 units
DistributionNationwide to hospitals Foreign: Australia, Africa, Belgium, Canada, China, Dubai, Egypt, Germany, D\Godmanchester, Italy, Japan, Korea, Malaysia, Norway, Portugal, Singapore, South Africa, Thailand, Taiwan.
Total Product Life CycleTPLC 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.
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