BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor
FDA device recall Z-2215-2013 · posted 2013-09-17 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Reason for recall
- Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 43385 US
- Distribution
- Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland,
- Date initiated
- 2013-08-06
- Date posted
- 2013-09-17
- Date terminated
- 2016-04-20
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318 (K031685) | Smith & Nephew, Inc. | 2003-07-01 |