Arthro-Knife, ConMed, Linvatec 11311 Concept Blvd, Largo FL 33773, Made in USA. RX only. U.S. PAT NO. 5.141.517. The Art
FDA device recall Z-0067-2010 · posted 2009-10-21 · Terminated
Recall details
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Reason for recall
- ConMed has determined there is a possibility that the device may not fully retract once it is deployed.
- Action taken
- ConvaMed Linvatec USA issued an "Urgent Medical Device Recall" notification via Fed Ex to all direct consignees of the affected product. Users were asked to inventory and return all affected product to the firm and to return a reply form by mail or fax. For further information, contact customer service at 1-800-237-0169 for US or your local ConMed Linvatec office for outside US or email at Custserv1@linvatec.com.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HST
- Quantity affected
- Approximately 66,144 products.
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-07-31
- Date posted
- 2009-10-21
- Date terminated
- 2011-02-25
- Location
- Largo, FL
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