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U.S. Department of Health and Human Services

Class 2 Device Recall BIORAPTOR 2.9 mm Suture Anchor

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  Class 2 Device Recall BIORAPTOR 2.9 mm Suture Anchor see related information
Date Initiated by Firm August 06, 2013
Date Posted September 17, 2013
Recall Status1 Terminated 3 on April 20, 2016
Recall Number Z-2216-2013
Recall Event ID 66037
510(K)Number K031685  
Product Classification Screw, fixation, bone - Product Code HWC
Product BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774

Biodegradable suture anchor
Code Information 50252956 50253511 50255944 50257231 50257887 50258391 50259146 50259750 50259821 50260686 50261428 50262956 50263219 50263661 50264102 50265258 50266339 50266927 50267570 50268569 50269026 50269813 50270372 50271272 50271909 50272355 50273934 50274664 50275118 50276255 50276806 50277167 50277785 50278253 50278900 50279470 50280271 50280510 50281120 50281481 50281875 50282158 50282541 50283320 50283827 50285048 50285421 50286293 50286609 50287487 50287743 50288414 50288712 50289363 50290038 50290548 50291351 50292241 50293608 50294169 50294378 50295261 50297038 50298069 50299385 50299683 50300671 50301473 50302325 50303059 50303150 50303787 50304658 50305102 50305723 50306820 50307460 50308223 50308654 50309005 50309760 50309927 50310434 50310774 50310860 50311917 50312590 50314382 50315219 50315411 50315799 50316169 50316263 50316662 50316990 50317055 50317280 50317454 50317458 50317464 50317995 50318784 50319133 50319545 50320231 50321239 50323634 50324606 50325731 50326560 50327214 50328866 50330833 50331688 50332902 50333546 50333779 50338800 50339831 50341603 50342909 50344379 50345301 50345318 50346210 50348330 50348512 50349830 50350260 50350691 50351144 50351956 50352210 50353153 50353605 50354092 50354530 50355121 50356403 50356622 50357089 50357390 50358104 50358384 50358570 50358737 50360444 50360805 50361888 50362229 50363185 50363892 50364660 50364943 50366146 50366306 50367859 50369187 50370318 50370807 50371620 50372061 50372503 50372895 50373328 50375326 50376603 50378048 50378139 50379043 50381196 50382147 50385218 50385487 50385823 50386382 50388029 50388738 50388904 50390494 50391246 50392389 50394523 50395091 50396670 50398546 50399426 50401028 50402074 50402820 50404404 50405090 50405697 50405889 50409820 50407935 50408209 50410766 50411053 50411900 50412271 50413139 50414779 50414982 50415491 50416313 50417008 50417522 50418330 50418858 50421496 50430179 50430392 50435315 50437094 50437346 50438202 50440209 50441677 50442744 50443592 50444060 50445031 50445515 50445520 50447262 50448595 50450276 50451218 50453799 50455193 50458413 50459732 50460345 50461686 50462370 
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
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 24574 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 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.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = SMITH & NEPHEW, INC.
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