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SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly protector, with protectio...

FDA Recall #Z-0578-2013 — Class II — December 3, 2012

Recall #Z-0578-2013 Date: December 3, 2012 Classification: Class II Status: Terminated

Product Description

SOL SYS 8IN CALC 1.5/19.5 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.

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

Recalling Firm

DePuy Orthopaedics, Inc. — Warsaw, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

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

Code Information

Product Code: 157215195 and Lot codes: 126367, A34FG1000, A63GS1000, B19HM1000, B3DE61000, B46AJ1000, BY6G81000, C4YBH1000, C5FH81000, CB9L21000, CH7EH1000, CP8NJ1000, D83FY1000, DG1PB1000, X24EW1000, X24EX1000, X24EY1000, X24EYB000, X3DC51000, X5SB31000, X5SB3A000, YA6GT1000, YF6AE1000, YF6AEA000, Z5VAN1000, and Z5VANB000.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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