Z-0828-2013Class I

LPS Diaphyseal Sleeves

Name: Z-0828-2013 LPS Diaphyseal Sleeves
Creator: DePuy Orthopaedics, Inc.
Published: 2013-01-04
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2013-01-04 / Terminated / root cause: design

FDA source

DePuy Orthopaedics, Inc. began a recall of 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... on 2013-01-04. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0828-2013
Classification: Class I
Status: Terminated
Initiated: 2013-01-04
Posted: 2013-02-15
Terminated: 2014-05-20
Recalling firm: Depuy Orthopaedics Inc.
Product: 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.
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 162 total units (US) and 102 units total (OUS)
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 codes and lots: Part number: 198720018 and Lot numbers: 123506, 123507, 156208, 188414, 202951, 212351, B34GC1000, B4EGN1000, B4SBM1000, B5SHY1000, DH8F91000, DH8F9A000, DH8F9B000, DH8F9C, and FE5LL1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0828-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0828-2013	Class I	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-15
Z-0829-2013	Class I	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-15
Z-0830-2013	Class I	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-15
Z-0831-2013	Class I	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-15

Product code MBH

K071417Class IIDepuy Lps Diaphyseal and Metaphyseal SleevesDePuy Orthopaedics, Inc. / cleared 2007-08-02

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)