TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biodegradable suture anchor
This recall has been terminated (originally issued September 17, 2013).
- Recall Initiated
- August 6, 2013
- Posted
- September 17, 2013
- Terminated
- April 20, 2016
- Recall Number
- Z-2235-2013
- Quantity
- 1308 US
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
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.
Lot / Code Info
50325164 50326837 50336721 50336771 50339645 50339841 50341067 50341975 50344394 50349837 50350415 50351794 50359331 50363876 50368160 50370201 50372046 50375166 50377788 50378916 50380676 50381053 50388605 50392271 50392403 50395799 50403938 50411076 50417379 50422358 50433010 50433121 50438323 50448200 50460082
Root Cause
Packaging
Action Taken
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.