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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer

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  Class 2 Device Recall Zimmer see related information
Date Initiated by Firm January 11, 2016
Date Posted March 12, 2016
Recall Status1 Terminated 3 on April 13, 2017
Recall Number Z-1128-2016
Recall Event ID 72900
510(K)Number K830196  
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
Product Product 30 consists of all product under product code: KTT and same usage:
Item no:
118100527 FREE-LOCK LAG SCREW, 12.7
118100535 FREE-LOCK LAG SCREW, 12.7
118100540 FREE-LOCK LAG SCREW, 12.7
118100542 FREE-LOCK LAG SCREW, 12.7
118101022 FREE-LOCK LAG SCREW, 12.7
118101025 FREE-LOCK LAG SCREW, 12.7
118101027 FREE-LOCK LAG SCREW, 12.7
118101030 FREE-LOCK LAG SCREW, 12.7
118101032 FREE-LOCK LAG SCREW, 12.7
118101035 FREE-LOCK LAG SCREW, 12.7
118101037 FREE-LOCK LAG SCREW, 12.7
118101040 FREE-LOCK LAG SCREW, 12.7
118101042 FREE-LOCK LAG SCREW, 12.7
118101045 FREE-LOCK LAG SCREW, 12.7
118101047 FREE-LOCK LAG SCREW, 12.7
118101052 FREE-LOCK LAG SCREW, 12.7
118101055 FREE-LOCK LAG SCREW, 12.7
118101057 FREE-LOCK LAG SCREW, 12.7
118101522 FREE-LOCK LAG SCREW, 15.8
118101525 FREE-LOCK LAG SCREW, 15.8
118101527 FREE-LOCK LAG SCREW, 15.8
118101530 FREE-LOCK LAG SCREW, 15.8
118101532 FREE-LOCK LAG SCREW, 15.8
118101547 FREE-LOCK LAG SCREW, 15.8
118109010 FREE-LOCK SUPRACOND TUBE/
118109510 FREE-LOCK SUPRACOND TUBE/
118113005 FREE-LOCK TUBE & SCP PLAT
118113006 FREE-LOCK TUBE & SCP PLAT
118113010 FREE-LOCK TUBE & SCP PLAT
118113504 FREE-LOCK TUBE & SCP PLAT
118113505 FREE-LOCK TUBE & SCP PLAT
118113506 FREE-LOCK TUBE & SCP PLAT
118113508 FREE-LOCK TUBE & SCP PLAT
118113510 FREE-LOCK TUBE & SCP PLAT
118113594 FREE-LOCK TUBE & SCP PLAT
118114005 FREE-LOCK TUBE & SCP PLAT
118114006 FREE-LOCK TUBE & SCP PLAT
118114008 FREE-LOCK TUBE & SCP PLAT
118114010 FREE-LOCK TUBE & SCP PLAT
118114012 FREE-LOCK TUBE & SCP PLAT
118114004 FREE-LOCK TUBE & SCP PLAT
118114008 FREE-LOCK TUBE & SCP PLAT
118114010 FREE-LOCK TUBE & SCP PLAT
118114012 FREE-LOCK TUBE & SCP PLAT
118114504 FREE-LOCK TUBE & SCP PLAT
118114505 FREE-LOCK TUBE & SCP PLAT
118114506 FREE-LOCK TUBE & SCP PLAT
118114508 FREE-LOCK TUBE & SCP PLAT
118114512 FREE-LOCK TUBE & SCP PLAT
118114594 FREE-LOCK TUBE & SCP PLAT
118114508 FREE-LOCK TUBE & SCP PLAT
118114512 FREE-LOCK TUBE & SCP PLAT
118114594 FREE-LOCK TUBE & SCP PLAT
118115004 FREE-LOCK TUBE & SCP PLAT
118115005 FREE-LOCK TUBE & SCP PLAT
118115006 FREE-LOCK TUBE & SCP PLAT
118115008 FREE-LOCK TUBE & SCP PLAT
118115094 FREE-LOCK TUBE & SCP PLAT
118113508 FREE-LOCK TUBE & SCP PLAT
118113506 FREE-LOCK TUBE & SCP PLAT
118113505 FREE-LOCK TUBE & SCP PLAT
118113504 FREE-LOCK TUBE & SCP PLAT
118113004 FREE-LOCK TUBE & SCP PLAT


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.
Code Information lot no.: 61982436 61867365 61886667 61886668 61820722 61897702 61977095 61799436 61934575 61828057 61982437 61828048 61934576 61798403 61906719 62031688 62197641 61663372 61828049 61886669 61828050 62031689 61828053 62106374 61828054 62033051 62197643 61828055 61906715 61982438 61867334 61977096 61927725 61784953 61867368 61849821 61849827 61906712 62124274 62120943 61785930 61771006 61826981 61895080 61902197 61827363 61888704 61895083 62255904 61902213 61990124 61753044 62271887 61850459 61778818 61778840 61827350 61827352 61827355 61853069 61865454 61865455 61888705 61895087 61897708 61897709 61897711 61900062 61941016 61941017 61958817 61990133 62127925 62130793 62130794 62241680 62255912 62255914 62255920 62271894 61902217 61958146 62271889 61958147 61955869 62105421 61860644 61888706 61937605 370531 61853081 61870427 62230186 61777469 61923868 61940612 61940613 370989 61853082 61955870 61890945 61930189 61859417 61923869 61788809 61829108 370516 61860640 61874946 370515 370959 370956 61843251 61937601 62105422 371015 61895079 61788813 61849271 371014 370517 61860668 61869716 61874978 370990 370923 61891507 371071 61902208 370955 
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 2		 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 3500
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 = KTT and Original Applicant = ZIMMER, INC.
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