SPIDER Surgical Platform The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-sterilized and is a single use device.
FDA Recall Z-1909-2011 · Posted 2011-04-08
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Recalling FirmTransenterix, Inc
Recall StatusTerminated
Product CodeGCJ
Date Initiated2011-02-25
Date Terminated2011-11-07
Product Quantity305 units
Reason for Recall
Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery.
Firm Action
TransEnterix sent an Urgent Device Recall letter dated February 25, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the lot numbers affected, complete the attached inventory reconciliation form and return the form, along with any affected product to
TransEnterix using the enclosed shipping label.
Customers were asked to return the inventory form even if they had none of the lot numbers affected in their inventory.
Their sales representative and customer service will work with them to replace the product in full at not cost to them.
For questions regarding this recall contact TransEnterix Customer Care at 1-888-879-4111.
Root Cause
Other
Distribution Pattern
Nationwide Distribution including AZ, FL, NC, NY, OH, OR, SC, TX, VA and WA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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