Recalls / —

—#117658

Product

Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.

FDA product code

HTY — Pin, Fixation, Smooth

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K970733

Affected lot / code info

Part Number 450.851S, Lot Number 7065061

Why it was recalled

Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.

Root cause (FDA determination)

Packaging process control

Action the firm took

A letter dated April 18, 2013 was sent to one consignee who was identified as receiving the affected device. A review of inventory and return of any affected product on hand was requested. Negative responses were also requested.

Recalling firm

Firm

Synthes USA HQ, Inc.

Address

1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern

US distribution to MA.

Timeline

Recall initiated

2013-04-18

Posted by FDA

2013-09-18

Terminated

2015-03-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #117658. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.