Recall Z-0696-2020
Smith & Nephew, Inc. · initiated November 11, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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…
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: Device Design
Action taken
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.
Details
- Recall number
- Z-0696-2020
- Initiated
- November 11, 2019
- Terminated
- May 7, 2021
- Product code
- GFJ – Mallet, Surgical, General & Plastic Surgery
- Quantity
- 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.
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN