SOL SYS L 9IN CALC 2.25/16.5 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.
This recall has been terminated (originally issued December 20, 2012).
- Company
- Depuy Orthopaedics, Inc.
- Recall Initiated
- December 3, 2012
- Posted
- December 20, 2012
- Terminated
- November 13, 2013
- Recall Number
- Z-0581-2013
- Quantity
- 1732 total all product codes
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
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
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
Lot / Code Info
Product Code: 157225165 and Lot codes: 105802, A19GM1000, A38B61000, B28JL1000, B2PAV1000, BB6KJ1000, C49A91000, C4JCS1000, C6ACS1000, CD1ET1000, CK3E71000, DH9JX1000, E3TF91000, E5LCS1000, EF1ES1000, FF8DW1, X32HF1000, X43DG1000, X4GEJ1000, X4GEK1000, X4GEM1000, X4GEMB000, X5RED1000, X78CM1000, YG1B51000, YG1B5A000, Z2HC31000, and Z81H71000.
Root Cause
Device Design
Action Taken
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.