Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
FDA Recall Z-0395-2014 · Posted 2013-11-26
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Recalling FirmSynthes USA HQ, Inc.
Recall StatusTerminated
Product CodeNKB
Date Initiated2012-09-07
Date Terminated2015-12-18
Product Quantity757
Reason for Recall
This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.
Firm Action
Synthes sent an Urgent: Medical Device Product Removal letter on September 7, 2012, to all affected consignees. Consignees were requested to immediately cease using the product, examine their inventory and remove the parts from inventory. If they had the parts, they were further instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the verification section at the end of the letter and return the verification form. If they did not have the parts, they were requested to complete the verification section at the end of the letter and return the verification form. Consignees with questions were instructed to call 610-719-5450.
For questions regarding this recall call 610-719-5000.
Root Cause
Use error
Distribution Pattern
Nationwide Distribution including CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
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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