Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoate

FDA device recall Z-0569-2013 · posted 2012-12-19 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

DePuy Orthopaedics, Inc. is issuing a voluntary recall of ten lots of the Pinnacle Cancellous Screw due to an incorrect description on the label. The label description reads Pinnacle Cannulated Screw and should read Pinnacle Cancellous Screw.

Action taken

The firm, DePuy Orthopedics, Inc., sent an "URGENT INFORMATION - MEDICAL DEVICE RECALL NOTICE" dated July 2012 to its customers via email and mail. The notice described the product, problem and actions to be taken. The customers were instructed to determine whether they would like to retain and use the product or return affected product to DePuy in Warsaw, IN, and to complete and return the Reconciliation forms to your DePuy Sales Representative or by fax to: 574-371-4939. DePuy sales representatives are expected to aid customers in returning of recalled products. For questions about recall information provided, please contact the Manager, Post-Market Surveillance, 574-372-7333 (M-F; 8 am - 5 pm EDT.)

Root cause

Labeling Change Control

Status

Terminated

Product code

LPH

Quantity affected

118 units

Distribution

Nationwide distribution: USA states of: GA, MA, MN, SC and VA.

Date initiated

2012-11-28

Date posted

2012-12-19

Date terminated

2013-03-20

Location

Warsaw, IN

Related 510(k) clearances