—#122362

Product

Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.

FDA product code: KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K041911
Affected lot / code info: Part No. 02.001.324, lot no. 6900823

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Worldwide Distribution - USA including ID, FL, TN, NY, LA and Internationally to Canada.

Timeline

Recall initiated: 2013-07-30
Posted by FDA: 2013-11-27
Terminated: 2015-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122362. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.