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LPS Diaphyseal Sleeves recallZ-0828-2013 · DePuy Orthopaedics, Inc. · initiated Jan 4, 2013

Class I Terminated All recalls posted in February 2013

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

DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.

FDA root cause category: Device Design

What the company is doing

DePuy Othopaedics sent an Urgent Information Medical Device Recall Notice letter dated January 4, 2013 to all affected customers. The letter identified the affected products, reason for recall, clinical implications and actions to be taken. The letter instructed customers to check inventory, discontinue use, cease further distribution and return all inventory on hand for credit. Customers were requested to complete and return the Reconciliation Form. For product-related questions contact your local DePuy Othopaedics Sales Representative, clinical questions contact DePuy's Scientific Information Office at 1-888-554-2482 and recall notice information call 574-372-7333.

Recall details

Recall number
Z-0828-2013
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Jan 4, 2013
Posted by the FDA
Feb 15, 2013
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
162 total units (US) and 102 units total (OUS)
Product code
MBH
FDA submissions
K071417
Distribution
Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, GA, ID, IL, MA, MD, MI, MN, NC, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV and the countries of Holland, Australia, Austria, South Africa and Canada including Veteran Administration hospitals.

Product description

LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.

Code information (models, lots, serial numbers)

Part number: 198720018 and Lot numbers: 123506, 123507, 156208, 188414, 202951, 212351, B34GC1000, B4EGN1000, B4SBM1000, B5SHY1000, DH8F91000, DH8F9A000, DH8F9B000, DH8F9C, and FE5LL1.

Other devices under the same FDA submission

3 devices cleared under K071417 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 63783).

Sources and updates

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