CLASS I Device recall · Reported 27 Feb 2013 · FDA Enforcement Report

LPS Diaphyseal Sleeves recalled by DePuy Orthopaedics

DePuy Orthopaedics is recalling LPS Diaphyseal Sleeves, distributed nationwide in the US. The recall was initiated on 4 Jan 2013 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesPart number: 198720020 and Lot numbers: 140576, 156212, 156213, 156214, 162644, 188411, 202954, 156214A, 202954A, B34GD1000, B4SBN1000, B4SBNA000, B4SBNB000, B4SBNC000, B5RAW1000, B5RAWA000, C3RHJ1000, C74JX1000, C74JXA, E18N61000, E3PKV1000, EF8GB1000, and FL2WB1.

Quantity recalled162 total units (US) and 102 units total (OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0829-2013
FDA event ID: 63783
Recalling firm: DePuy Orthopaedics, Warsaw, IN
Classification: Class I
Status: Terminated
Recall initiated: 4 Jan 2013
FDA classified: 15 Feb 2013
Reported: 27 Feb 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

4 Jan 2013	Recall initiated by company
15 Feb 2013	Classified by FDA	+42 days
27 Feb 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama Arizona California Colorado Florida Georgia Idaho Illinois Massachusetts Maryland Michigan Minnesota North Carolina New Mexico Nevada New York Ohio Pennsylvania South Carolina South Dakota

Questions about this recall

Why was it recalled?

Which lots are affected?

Part number: 198720020 and Lot numbers: 140576, 156212, 156213, 156214, 162644, 188411, 202954, 156214A, 202954A, B34GD1000, B4SBN1000, B4SBNA000, B4SBNB000, B4SBNC000, B5RAW1000, B5RAWA000, C3RHJ1000, C74JX1000, C74JXA, E18N61000, E3PKV1000, EF8GB1000, and FL2WB1.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 63783

This product is part of a recall event; the main page for the event is LPS Diaphyseal Sleeves recalled by DePuy Orthopaedics.

Reported	Class	Recall	Company	Reason	Where
27 Feb 2013	CLASS I	LPS Diaphyseal Sleeves recalled by DePuy Orthopaedics	DePuy Orthopaedics	Packaging Defects	Nationwide
27 Feb 2013	CLASS I	LPS Diaphyseal Sleeves recalled by DePuy Orthopaedics	DePuy Orthopaedics	Packaging Defects	Nationwide
27 Feb 2013	CLASS I	LPS Diaphyseal Sleeves recalled by DePuy Orthopaedics	DePuy Orthopaedics	Packaging Defects	Nationwide

More recalls from DePuy Orthopaedics

All 153

Reported	Class	Recall	Company	Reason	Where
10 Apr 2024Device	CLASS II	Attune Affixium Cementless Fixed Bearing Knee recalled	DePuy Orthopaedics	Labeling Errors	Nationwide
29 Mar 2023Device	CLASS II	Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert SM recalled	DePuy Orthopaedics	Other	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide