Devices

Device Recall PFC Steinman Pin/Drill Pack Sterile (WPC 6672012)

Model / Serial
Product code: 864192 Lot: 167026,167034, 167035
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide distribution: USA including states of: FL, LA, TX, OR, CA, AZ, KY, GA, MS, and PA.
Product Description
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.
Manufacturer
DePuy Orthopaedics, Inc.
1 Event
- Recall of Device Recall PFC Steinman Pin/Drill Pack Sterile (WPC 6672012)

Manufacturer

DePuy Orthopaedics, Inc.

Manufacturer Address
DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
Manufacturer Parent Company (2017)
Johnson & Johnson
Source
USFDA

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