Recall Z-1426-2012 ยท LXH Orthopedic Manual Surgical Instrument
DePuy Orthopaedics, Inc.
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 i
| Date | Apr 16, 2012 (initiated Mar 12, 2012) |
| Status | Terminated |
| Reason | 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 | 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 Re |
| Quantity | 40 of each lot, 120 total |
| Distribution | Nationwide distribution: USA including states of: FL, LA, TX, OR, CA, AZ, KY, GA, MS, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.