Z-1426-2012

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

Name: Z-1426-2012 PFC Steinman Pin/Drill Pack Sterile (WPC 667-2012) Drill Bit and Steinman Pin Packet (1 unit) The PFC...
Creator: DePuy Orthopaedics, Inc.
Published: 2012-03-12
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2012-03-12 / Terminated / root cause: packaging

FDA source

DePuy Orthopaedics, Inc. began a recall of PFC Steinman Pin/Drill Pack Sterile (WPC 667-2012) Drill Bit and Steinman Pin Packet (1 unit) The PFC Steinman Pin/Drill Pack Sterile is part of the PFC... on 2012-03-12. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1426-2012
Status: Terminated
Initiated: 2012-03-12
Posted: 2012-04-16
Terminated: 2013-03-06
Recalling firm: Depuy Orthopaedics Inc.
Product: PFC Steinman Pin/Drill Pack Sterile (WPC 667-2012) Drill Bit and Steinman Pin Packet (1 unit) The PFC Steinman Pin/Drill Pack Sterile is part of the PFC Modular Knee Instrument system. The single pack (1 box) contains 2 pieces of 1/8 Target Drill Bit product code 513-4193-01 and 4 pieces of Steinman Pin product code 086-9117-00. The Drill Bits are 0.125 in diameter and 5 long. The Steinman Pins in this pack are 0.125 in diameter and 3 long. The pack is provided sterile to the customer and is intended for one time use. The contents of the pack provide stable fixation of the femoral or tibial cutting blocks to the bone while a cut is made.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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).
Quantity in commerce: 40 of each lot, 120 total
Distribution: Nationwide distribution: USA including states of: FL, LA, TX, OR, CA, AZ, KY, GA, MS, and PA.
Product codes and lots: Product code: 864192 Lot: 167026,167034, 167035

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)