Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.
FDA Recall Z-0409-2014 · Posted 2013-11-27
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Recalling FirmSynthes USA HQ, Inc.
Recall StatusTerminated
Product CodeKTT
Date Initiated2013-07-30
Date Terminated2015-08-31
Product Quantity13
Reason for Recall
The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.
Firm Action
Synthes sent an Urgent Notice: Medical Device Notification letter dated October 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to returny any of the affect devices, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section indicating the affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Return the Verification Form to:
Credit/Returns
Synthes
1101 Synthes Avenue
Monument, CO 80132
Customers were also instructed to return the Verification Section even if they don't have the affected product.
Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant.
For questions regarding this recall call 610-719-5000.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - USA including ID, FL, TN, NY, LA and Internationally to Canada.
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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