Class 2 Device Recall Zimmer

• Date Initiated by Firm: January 11, 2016
• Date Posted: March 12, 2016
• Recall Status: Terminated on April 13, 2017
• Recall Number: Z-1119-2016
• Recall Event ID: 72900
• 510(K)Number: K960658
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
• Product: Product 21 consists of all product under product code: JDI and same usage:; Item no: ; 811400218 CPT 12/14 COCR REVISION S; 811400318 CPT 12/14 COCR REVISION S; 811400420 CPT 12/14 COCR REVISION S; 811400423 CPT 12/14 COCR REVISION S; 811400426 CPT 12/14 COCR REVISION S; 811400010 CPT 12/14 COCR SIZE 0 EXT; 811400000 CPT 12/14 COCR SIZE 0 STD; 811400110 CPT 12/14 COCR SIZE 1 EXT; 811400100 CPT 12/14 COCR SIZE 1 STD; 811400210 CPT 12/14 COCR SIZE 2 EXT; 811400200 CPT 12/14 COCR SIZE 2 STD; 811400230 CPT 12/14 COCR SIZE 2 XEX; 811400310 CPT 12/14 COCR SIZE 3 EXT; 811400300 CPT 12/14 COCR SIZE 3 STD; 811400330 CPT 12/14 COCR SIZE 3 XEX; 811400410 CPT 12/14 COCR SIZE 4 EXT; 811400400 CPT 12/14 COCR SIZE 4 STD; 811400430 CPT 12/14 COCR SIZE 4 XEX; 811400510 CPT 12/14 COCR SIZE 5 EXT; 811400500 CPT 12/14 COCR SIZE 5 STD; 811400530 CPT 12/14 COCR SIZE 5 XEX; ; Product Usage:; Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
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• Recalling Firm/ Manufacturer: Zimmer Manufacturing B.V.; Turpeaux Industrial Park Rd 1 km 123.4; Mercedita PR 00715
• For Additional Information Contact: Consumer Relations Call Center; 800-447-5633
• Manufacturer Reason for Recall: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
• FDA Determined Cause: Packaging
• Action: Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.
• Quantity in Commerce: 1209
• Distribution: US Nationwide Distribution
• 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 = JDI and Original Applicant = ZIMMER, INC.