DePuy Orthopaedics, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0574-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

SOL SYS F 8 CALC 13.5MM LG 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 Classification:

Class II

Date Initiated: December 3, 2012

Date Posted: December 26, 2012

Recall Number: Z-0574-2013

Event ID: 63545

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

Status: Terminated

Product Quantity: 1732 total all product codes

Code Information:

Product Code: 157215136 and Lot codes: 169458, AB8F51000, AF1ED1000, AF1EDA000, AF1EG1000, AF1EGA000, AF1EGB000, AF7KH1000, AV7JX1000, AW8F11000, BR4J91000, BT9FM1000, BT9FMA000, BT9FMB000, C1PC61000, C35D51000, C35D5A000, C3WCX1000, C4YBF1000, C5FH51000, C5FH5A000, C77A71000, C77A7B, CG5B51000, CH1AE1000, CH1AEA000, CH1AEB000, CH1AF1000, D1TLE1000, D3RFF1000, D46LE1000, D52LY1000, D5FDJ1000, D74ER1000, DA8MC1000, DD6E51000, DG1N81000, DN5HY1000, DS7KB1000, E1RHH1000, E1RHHA000, E3SDE1000, E45LS1, E5LCW1, E65NEA, EB6DJ1000, EC3DJ1000, EF8HJ1000, EK8JR1000, ES6CV1000, EW2HF1000, EY2EG1000, FE9P31, FG2F21, FJ9L81, and FK9D41.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated