Class 2 Device Recall SOL SYS L 9IN CALC 2.25/18

• Date Initiated by Firm: December 03, 2012
• Date Posted: December 20, 2012
• Recall Status: Terminated on November 13, 2013
• Recall Number: Z-0582-2013
• Recall Event ID: 63545
• 510(K)Number: K060581
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
• Product: SOL SYS L 9IN CALC 2.25/18; ; 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.
• Code Information: Product Code: 157225180 and Lot codes: B19HN1000, B19HNA000, B3FAF1000, BF6A21000, C32GEA, C5PRY1000, C61CD1000, CD1EW1000, EE5K61000, X33GC1000, X49FV1000, X4KF91000, X4KGA1000, X4KGB1000, X5SB41000, X5SB4A000, X5SB4B000, X5SB4C000, Y14GJ1000, Y14GJA000, YD3H31000, YD3HY1000, YG8B11000, YH9E21000, and YH9E2B000.
• Recalling Firm/ Manufacturer: DePuy Orthopaedics, Inc.; 700 Orthopaedic Dr; Warsaw IN 46582-3994
• For Additional Information Contact: 574-267-8143
• Manufacturer 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
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LPH and Original Applicant = DEPUY ORTHOPAEDICS, INC.