• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Osteoraptor Suture Anchor

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Osteoraptor Suture Anchor see related information
Date Posted September 17, 2013
Recall Status1 Open
Recall Number Z-2221-2013
Recall Event ID 66037
510(K)Number K082215 
Product Classification Staple, fixation, bone - Product Code JDR
Product OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995

Biodegradable suture anchor
Code Information 50272329
50272466
50274208
50274464
50274790
50275814
50277799
50278266
50278994
50282166
50283019
50283839
50285057
50286656
50288421
50289813
50291359
50293118
50294563
50295608
50296649
50298065
50301017
50302318
50305467
50306821
50308347
50309211
50310089
50310614
50311296
50312591
50314389
50315223
50315419
50316180
50316679
50316987
50317481
50318376
50318532
50319543
50320363
50321935
50323084
50323631
50324184
50324789
50327218
50331339
50333094
50336659
50339177
50340628
50343607
50345140
50345975
50347750
50349688
50352034
50352998
50354277
50354523
50356122
50356984
50357948
50358554
50360002
50360656
50361750
50362641
50363887
50364918
50367858
50368809
50370314
50371912
50374779
50375720
50376835
50377822
50379209
50381376
50384165
50385364
50386748
50387839
50388736
50390940
50392275
50393329
50394520
50395793
50397073
50399277
50400560
50401454
50402073
50403117
50403703
50404630
50406026
50407298
50408207
50408986
50409815
50410646
50411754
50413578
50414258
50415462
50416319
50417212
50418095
50418678
50420659
50422216
50428378
50429372
50429659
50430185
50430406
50433943
50435810
50436716
50437246
50438205
50438744
50440212
50440606
50441444
50443360
50443860
50444062
50445142
50445316
50445551
50445552
50445553
50445555
50445556
50447139
50448325
50449126
50450279
50451524
50452588
50452764
50453646
50454691
50455485
50456543
50458419
50458609
50460107
50460693
50463955
50464113
50465465
50468475
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 17696 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
-
-