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OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 7220199...

FDA Device Recall #Z-2224-2013 — Class II — August 6, 2013

Recall Summary

Recall Number Z-2224-2013
Classification Class II — Moderate risk
Date Initiated August 6, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Smith & Nephew, Inc. Endoscopy Division
Location Andover, MA
Product Type Devices
Quantity 6373 US

Product Description

OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor

Reason for Recall

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Distribution Pattern

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.

Lot / Code Information

50261490 50270751 50270752 50272328 50272465 50274463 50275816 50277797 50281885 50282824 50284636 50286043 50289368 50294562 50295821 50299025 50302162 50307324 50309971 50315070 50316291 50318787 50321649 50323781 50326576 50327051 50328246 50329605 50330164 50330433 50333202 50333957 50334241 50335882 50338130 50338996 50340050 50340627 50342110 50344240 50347147 50348649 50349265 50352033 50352702 50354093 50355668 50356988 50358386 50358575 50360455 50361180 50364371 50364916 50364917 50367984 50370095 50370386 50372674 50372726 50372891 50374024 50375338 50375718 50381375 50385219 50385825 50387844 50388265 50389117 50389773 50390998 50392274 50392409 50397270 50398235 50399412 50399967 50400564 50401261 50401755 50402841 50403705 50405380 50406766 50407937 50408210 50408987 50412272 50412887 50415149 50415668 50416533 50417385 50418091 50419236 50421032 50423918 50429649 50430508 50431561 50435318 50436414 50437095 50437757 50438661 50439575 50441219 50442379 50444209 50445033 50445549 50445550 50446028 50447137 50448059 50448721 50449649 50449999 50450468 50450949 50452587 50453337 50454420 50455626 50456613 50457636 50458477 50458757

Other Recalls from Smith & Nephew, Inc. Endoscopy Division

Recall # Classification Product Date
Z-2045-2014 Class II SUTUREFIX Ultra Anchor XL with one (#2) Ultrabr... Jun 2, 2014
Z-2049-2014 Class II SUTUREFIX Ultra S Double Loaded Suture Product... Jun 2, 2014
Z-2046-2014 Class II SUTUREFIX Ultra Anchor XL with one (#2) Ultrabr... Jun 2, 2014
Z-2047-2014 Class II SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) ... Jun 2, 2014
Z-2048-2014 Class II SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (... Jun 2, 2014

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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