***REF C9944A***"FULL RADIUS RESECTOR"***2.9mm***Qty 6***STERLING***STERILE***Rx Only.*** Made in the USA***Manufacturer
FDA device recall Z-0987-2012 · posted 2012-02-10 · Terminated
Recall details
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Reason for recall
- ConMed Linvatec, Largo, FL recalled catalog number, C9944A, lot # 95987, 2.9MM Full Radius Resector Blade in November 2009 because there was a possibility that the device was assembled with an incorrect outer tube.
- Action taken
- A Linvatec Corporation dba ConMed Linvatec sales representative contacted the affected customers by telephone on November 12, 2009. The customers were also contacted by the Recall Coordinator. The product, problem, and action to be taken by the customers were discussed. Customers with the product in their inventory were instructed to return the product to the firm. Contact the firm at 727-399-5205 for questions regarding this recall.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- GFA
- Quantity affected
- 30 Units
- Distribution
- Product Distributed in the states of Georgia and New York.
- Date initiated
- 2009-11-12
- Date posted
- 2012-02-10
- Date terminated
- 2012-02-13
- Location
- Largo, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.