PFC Steinman Pin/Drill Pack Sterile (WPC 667-2012) Drill Bit and Steinman Pin Packet (1 unit) The PFC Steinman Pin/Drill

FDA device recall Z-1426-2012 · posted 2012-04-16 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

Sterility of the pins is at risk because product packaging, which is designed to include 2 pouches (inner pouch and outer pouch) around the pin mounting card only, contains a single pouch, which could compromise product sterility.

Action taken

The firm, DePuy Orthopedics Inc., sent an "URGENT INFORMATION - MEDICAL DEVICE RECALL NOTICE" dated March 12, 2012 to its customers via mail or in person with written communication. The notice described the product, problem and actions to be taken. The customers were instructed to cease use or distribution of recalled products and to return them to DePuy in Warsaw, IN. The sales representatives are expected to aid customer in returning of recalled products. Distributors and sales representatives are to return the recalled products through the normal DePuy Returns process, to attention of Returns and marking H12-01 on the outside of the box. The customers were also instructed to complete and return the Reconciliation Form to their Depuy Sales Representative or fax to 574-372-7567. Follow-ups for the Reconciliation Form for non-responders will be conducted with the Distributors until the form is returned. For Hospitals that are now out of business or refuse to sign the response card, the Distributor will indicate this on the Reconciliation form and return. For questions about the recall information provided, please contact Manager of Customer Quality, at 574-372-7333 (M-F; 8am - 5pm EST). For product-related questions, please contact your local DePuy Orthopaedics sales representative. For clinical-related questions from surgeons, please contact Depuy's Scientific Information Office at 1-888-554-2482 (M-F; 8am - 5pm EST).

Root cause

Packaging process control

Status

Terminated

Product code

LXH

Quantity affected

40 of each lot, 120 total

Distribution

Nationwide distribution: USA including states of: FL, LA, TX, OR, CA, AZ, KY, GA, MS, and PA.

Date initiated

2012-03-12

Date posted

2012-04-16

Date terminated

2013-03-06

Location

Warsaw, IN