Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this

FDA device recall Z-1125-2014 · posted 2014-03-04 · Terminated

Recall details

Recalling firm

Synthes, Inc.

Reason for recall

Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert).

Action taken

Synthes sent an Urgent Field Safety Notification/Medical Device Labeling Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Exchage the previously shipped package insert (GP0006) with the correct package insert (GP2848 provided with the notification). Review the package insert. Forward the Field Safety Notification to anyone in their facility that needs to be informed. If the package insert has been forwarded to another facility, contact that facility. Maintain awareness of this notice until all package inserts have been exchanged. Maintain a copy of the notice. Customers with questions were instructed to maintain a copy of the notice. For questions regarding this recall call 610-719-5000.

Root cause

Employee error

Status

Terminated

Product code

JDP

Quantity affected

45

Distribution

Nationwide Distribution including GA, CA, TX, MO, OH, PA, WA, AL, IN, AZ, MI, IA, TN, KY, NC, VA, NY, LA, IL, UT, and KS.

Date initiated

2014-02-05

Date posted

2014-03-04

Date terminated

2015-08-31

Location

West Chester, PA

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