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-1105-2016
• Recall Event ID: 72900
• 510(K)Number: K111447
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: Product 7 consists of all products under product code HWC, and same usage: Item no: 47234801435 3.5MM CORT SCR X 14MM 47234801635 3.5MM CORT SCR X 16MM 47234806535 3.5MM CORT SCR X 65MM 47234807035 3.5MM CORT SCR X 70MM 47234807535 3.5MM CORT SCR X 75MM 47234808035 3.5MM CORT SCR X 80MM 47234808535 3.5MM CORT SCR X 85MM 47234809035 3.5MM CORT SCR X 90MM Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
• Code Information: lot no: 62230449 62081271 62133855 62159156 62047629 62127760 61903333 62261628 61830478 61830479 62138082 62230452 61800380 61800381
• 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: 109
• 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 = HWC