RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 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-2237-2013
- Quantity
- 1965 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
50268918 50273148 50273920 50275809 50275812 50282175 50291658 50293289 50296525 50296650 50298707 50305798 50305840 50312502 50312528 50314834 50340632 50343203 50349591 50351817 50358580 50371915 50376235 50387881 50390367 50394081 50396639 50396640 50396641 50399818 50403721 50405089 50412292 50415521 50416545 50418333 50445533 50447145 50454703 50456549 50460175 50460177 50461710 50469565
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.