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U.S. Department of Health and Human Services

Class 2 Device Recall PROFIX Mallet

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  Class 2 Device Recall PROFIX Mallet see related information
Date Initiated by Firm November 11, 2019
Create Date December 17, 2019
Recall Status1 Terminated 3 on May 07, 2021
Recall Number Z-0696-2020
Recall Event ID 84325
Product Classification Mallet, surgical, general & plastic surgery - Product Code GFJ
Product smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.
Code Information Lot Numbers: 17AM17766 17AM17767 17CM01798 17CM01799 17CM01800  17CM01801 17CM01802 17CM01803 17CM01804 17CM01805 17CM01806  17CM01807 17CM02636 17CM02637 17CM02638 17CM02639 17CM02640 17CM02641 17CM02641A 17CM02642 17CM02643 17CM02644 17CM02645  17CM02646 17CM02647 17CM02648 17CM05047 17CM05048 17CM05049  17CM05050 17CM05050A 17CM05051 17CM05052 17CM05053 17CM05054  17CM05055 17CM05056 17CM05057 17CM05058 17CM05059 17CM07985  17CM07986 17CM07987 17CM07988 17CM10164 17CM10166 17CM10168  17CM15488 17CM15490 17CM15492 17CM15493 17CM15494 17CM15496  17CM15499 17CM19463 17CM19464 17CM19466 17CM19468 17CM19469  17CM19470 17CM19471 17CM19473 17DM03540 17DM03542 17DM03544  17DM03545 17DM03547 17DM03548 17DM03549 17DM03550 17DM03551  17DM03552 17DM03553 17DM10064 17DM10066 17DM10069 17DM10072  17DM14585 17DM14586 17DM14587 17DM14588 17DM14589 17DM14590  17EM00408 17EM00409 17EM00410 17EM00412 17EM00413 17EM00414  17EM00415 17EM00416 17EM00417 17EM00419 17EM00420 17EM00421  17EM00422 17EM00423 17EM00424 17EM05703 17EM05704 17EM05705  17EM05706 17EM05712 17EM10828 17EM10828A 17EM10829 17EM10830  17EM15105 17EM15106 17EM15107 17EM15108 17EM15109 17EM15110  17EM21229 17EM21230 17EM21233 17EM21236 17EM21238 17EM21239  17EM21242 17EM21245 17FM09954 17FM09955 17FM09956 17FM09957  17FM09958 17FM09959 17FM09959A 17GM07654 17GM07655 17GM07656  17GM07657 17GM07658 17GM07659 17GM07660 17GM07661 17GM07662  17GM07663 17GM07664 17GM07665 17GM07677 17GM07678 17GM07679  17GM07680 17GM07681 17GM07682 17GM07683 17GM07684 17GM07685  17GM07686 17GM07687 17GM07688 17GM10245 17GM12933 17GM12934  17GM12935 17GM15687 17GM15688 17GM15689 17GM15690 17JM01118  17JM04860P 17JM09449 17JM10724 17JM11956 17JM11957 17KM04646  17KM08204 17KM08207 17LM10125 17LM11933 17LM14786 17LM15874  17LM15875 17MM05227 17MM05228 17MM10461 18KK00010 18KK00070  18LK00128  
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact David Snyder
901-396-2121
Manufacturer Reason
for Recall		 There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occurs, particles generated in the poly thread potentially could enter the surgical field or a delay in surgery could occur if the tip disengages during the use of the mallet.
FDA Determined
Cause 2		 Device Design
Action The firm disseminated a medical device field correction notice on 11/11/2019 by letter. The letter explained the failure and requested the following actions be taken by hospital representatives: 1. Please check your inventory and complete the attached Inventory Correction Certification Form. 2. If you have the PROFIX 750 Gram Mallet, please maintain awareness of this notice. 3. When preparing for cleaning, disassemble the poly tip from the mallet and inspect disassembled components for damage or wear. 4. After cleaning, inspect disassembled components and ensure the components can be re-assembled securely. 5. Ensure the PROFIX 750 Gram Mallet is sterilized in the disassembled state. 6. After sterilization, ensure the poly tip is re-assembled to the mallet securely.
Quantity in Commerce 1371 devices
Distribution Worldwide distribution - US Nationwide distribution and countries of Belgium, Canada, China, Columbia, Costa Rica, Finland, France, Germany, Great Britain, Hong Kong, Italy, Netherlands, Norway, Panama, Poland, Switzerland, United Arab Emirates, Venezuela.
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.
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