Z-0591-2013Class II

SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as...

Name: Z-0591-2013 SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as...
Creator: DePuy Orthopaedics, Inc.
Published: 2012-12-03
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2012-12-03 / Terminated / root cause: design

FDA source

DePuy Orthopaedics, Inc. began a recall of SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then... on 2012-12-03. FDA classified it as Class II and gives the reason as "An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of...". 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-0591-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-03
Posted: 2012-12-20
Terminated: 2013-11-13
Recalling firm: Depuy Orthopaedics Inc.
Product: SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a
Root cause tag: design
FDA root cause: Device Design
Action: Deputh Orthopaedics sent an Urgent Information - Medical Device Recall Notice dated December , 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The notification letter instructed consignees to please cease further distribution or use of products immediately. The purpose of the communication was to inform them of this recall and request acknowledgement of receipt of this letter by their facility. Reconciliation forms should be returned to your DePuy Sales Representative or faxed to the following Fax Number: 574-371-4939. For questions regarding this recall call 574-267-8143.
Quantity in commerce: 1732 total all product codes
Distribution: Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR
Product codes and lots: Product Code: 157226210 and Lot codes: X43EX1000, X43EXA000, X43EY1000, X49FH1000, X4GDG1000, X57HX1000, and YH1ENA000.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0591-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0573-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0574-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0575-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0576-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0577-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0578-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0579-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0580-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0581-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0582-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0583-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0584-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0585-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0586-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0587-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0588-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0589-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0590-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0591-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20
Z-0592-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20

Product code LPH

K060581Class IIDepuy Solution System Hip ProsthesisDePuy Orthopaedics, Inc. / cleared 2006-05-19

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)