Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
FDA Recall Z-1823-2015 · Posted 2015-06-22
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Recalling FirmX Spine Systems Inc
Recall StatusTerminated
Product CodeMNH
Date Initiated2015-04-07
Date Terminated2015-10-01
Product Quantity75 units
Reason for Recall
The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
Firm Action
X-Spine sent an Urgent Medical Device Recall Letter dated April 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Actions to be taken:
1. The affected hospital and surgeon should be notified of this recall immediately.
2. Complete the attached Medical Device Recall Return Response Form and return it with any affected
product in inventory to X-Spine Systems immediately.
a. Reference RMA # 5410
b. Use enclosed shipping label
3. No action should be taken with product that has been implanted.
Please feel free to contact me at 800.903.0640 ext. 137.
Root Cause
Other
Distribution Pattern
Worldwide Distribution - US Distribution to the states of : FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA and TX., and to the countries of Austria, Germany and Italy.
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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