Class 2 Device Recall Zimmer Trabecular Metal

• Date Initiated by Firm: January 10, 2014
• Date Posted: February 26, 2014
• Recall Status: Terminated on September 11, 2014
• Recall Number: Z-1092-2014
• Recall Event ID: 67067
• 510(K)Number: K041549
• Product Classification: Prosthesis, shoulder, non-constrained, metal/polymer cemented - Product Code KWT
• Product: 00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabecular Metal Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1, Rx Product Usage: Zimmer Trabecular Metal TM Humeral Stem is a shoulder prosthetic replacement device that is indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint as well as humeral fractures. The humeral stem uses. Trabecular Metal around the proximal part of the stem for biological ingrowth.
• Code Information: lot 62267250
• Recalling Firm/ Manufacturer: Zimmer, Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 877-946-2761
• Manufacturer Reason for Recall: This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required specification. Testing found bond strength approximately 80% of the minimum required by specification in one of the three zones of the Trabecular Metal. The other two zones exceeded the minimum specification.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Zimmer sent an Urgent Medical Device Recall dated January 10, 2014 to distributors via electronic mail. The hospital/surgeon that has implanted this manufacturing lot will be identified and notified by the distributor. The letter identified the affected product, problem and actions to be taken. Distributors were instructed to locate and remove the affected product in their territory, as well as identifying and notifying the hospital/surgeon that has implanted this manufacturing lot as applicable. The distributor will return on-hand affected products to Zimmer and ensure all of their products are accounted for using the return form provided in the letter. Distributors and hospital consignees are to complete and return the inventory return form and acknowledgement form indicating which hospital/surgeon has implanted the product and to which they have provided notice to. Email a copy of the completed return form to CorporateQuality.PostMarket@Zimmer.comCommunications outside of the United States will occur approximately two weeks after the United States communications. For questions call 1-877-946-2761
• Quantity in Commerce: 10 units
• Distribution: Distribution USA in the state of Illinois.
• 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 = KWT