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U.S. Department of Health and Human Services

Class 2 Device Recall Osteoraptor Suture Anchor

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 Class 2 Device Recall Osteoraptor Suture Anchor see related information
Date Posted September 17, 2013
Recall Status1 Open
Recall Number Z-2228-2013
Recall Event ID 66037
510(K)Number K082215 
Product Classification Staple, fixation, bone - Product Code JDR
Product OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290

Biodegradable suture anchor
Code Information 50364854
50366872
50366972
50366980
50366985
50366989
50370760
50370771
50370940
50371292
50376475
50385813
50386237
50386563
50386749
50388066
50391012
50394695
50396184
50400301
50400306
50400307
50403488
50404241
50406445
50407524
50407571
50410789
50411371
50414977
50415258
50415670
50416148
50417206
50418093
50418993
50420658
50423443
50429652
50430190
50430402
50431731
50433933
50435319
50441441
50442649
50444415
50445034
50445760
50447482
50448060
50448722
50450469
50451783
50453148
50454104
50455627
50456912
50458608
50460242
Recalling Firm/
Manufacturer
Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
978-749-1073
For Additional Information Contact Albert A. Pytka
978-749-1073
Manufacturer Reason
for Recall
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
FDA Determined
Cause 2
Packaging
Action Smith&Nephew sent an Urgent Product Recall Notification letter dated August 6, 2013, via Federal Express to all affected customers. Addendum customer letters for 4 additional part numbers were sent via Federal Express on August 19, 2013, The letters identified the product, the problem, and the action to be taken by the customer. Customers were asked to inspect their inventory, locate unused devices and quarantine them. Customers were also asked to complete the last three columns in the inventory Return Certification form indicating the quantities that need to be returned, and include their contact information in the spaces provided. Customers were instructed to contact Smith & Nephew's Demo Service Departmentat 800-343-5717 for a Return Authorization (RA#), and provide the information response form. Replacement product would be provided. For questions regarding this recall call 978-749-1073.
Quantity in Commerce 10296 US
Distribution Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JDR and Original Applicant = SMITH & NEPHEW INC., ENDOSCOPY DIVISION
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