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SIGMA LCS recallZ-0787-2016 · DePuy Orthopaedics, Inc. · initiated Jan 8, 2016

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from DePuy Orthopaedics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin. Surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space. Insert Dislocation or Spin Out, or Poor Joint Mechanics may result, if not noted during surgery. May require revision surgery.

FDA root cause category: Component design/selection

What the company is doing

On 1/8/2016, URGENT INFORMATION RECALL NOTICE for Specific Lots of SIGMA High Performance (HP) MBT Non-Keel Punch Knee Instrument notifications were sent to the affected distributors and Medical Professionals with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc.s Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m. 5 p.m. EDT). For questions about the device recall information provided, please contact Kim Earle, Senior Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. 5 p.m. EDT).

Recall details

Recall number
Z-0787-2016
Status
Terminated
Initiated by the company
Jan 8, 2016
Posted by the FDA
Feb 9, 2016
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
351
Product code
LRY
Distribution
Worldwide Distribution-US Nationwide, Armenia, Australia, Austria, Belgium, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, P R China, Portugal, Poland, Russia, Singapore, Slovenia, South Africa, Spain, Sweden, South Korea, Switzerland, Thailand, Turkey, UAE, UK, and Brazil.

Product description

SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction.

Code information (models, lots, serial numbers)

Cat. No. GTIN Lot Description  950502016 10603295227366 ABB92402 SIGMA HP MBT Cemented Punch size 1-1.5  950502017 10603295227373 ABB84491 SIGMA HP MBT Cemented Punch size SZ 2-3  950502018 10603295227380 ABB92358 SIGMA HP MBT Cemented Punch size SZ 4-7  950502020 10603295227403 ABC33125 SIGMA HP MBT Noncemented Punch size 2-3  950502020 10603295227403 ABB81733 SIGMA HP MBT Noncemented Punch size SZ 2-3  950502020 10603295227403 ABB81732 SIGMA HP MBT Noncemented Punch size SZ 2-3  950502021 10603295227410 ABB39952 SIGMA HP MBT Noncemented Punch size SZ 4-7  950502021 10603295227410 ABC33123 SIGMA HP MBT Noncemented Punch size SZ 4-7

Devices named in this recall

5 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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