Z-0577-2013 Class II Terminated
FDA device recall Z-0577-2013 was initiated by DePuy Orthopaedics, Inc. on Dec 3, 2012 and is designated Class II. 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… The recall status is terminated (terminated Nov 13, 2013). Affected quantity: 1732 total product codes.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 26, 2012
- Initiation Date
- Dec 3, 2012
- Termination Date
- Nov 13, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1732 total product codes
Product Description
SOL SYS 8IN CALC 1.5/18.0 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
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
Code Information
Product Code: 157215180 and Lot codes: 116897, 126366, A63GP1000, A63GPA000, AP2BD1000, B19CL1000, B19CLA000, B19CLC000, B3DE71000, B3DE7A000, B5CA41000, C1PDC1000, C4YBG1000, C4YBGB, CB1EX1000, CC5JR1000, CH1AC1000, CH7EG1000, CL5PF1000, DD3BT1000, DD3BTA000, DH9JW1000, E1KKA1000, EC8DY1000, ET4FH1000, FB8RA1, FG9KV1, X2HD31000, X2HD41000, X2HD4B000, X2HD4C000, X2HD4D000, X2HD51000, X2HD5A000, X5REB1000, X5REBB000, XY7F71000, YA6GS1000, YG3DE1000, YH8AK1000, YH8AKA000, and Z5VAP1000.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0577-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026