CLASS II Device recall · Reported 25 Dec 2019 · FDA Enforcement Report

Profix Mallet recalled by Smith & Nephew

Smith & Nephew is recalling smith&nephew Profix Mallet, distributed nationwide in the US. The recall was initiated on 11 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Quantity recalled1371 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0696-2020
FDA event ID: 84325
Recalling firm: Smith & Nephew, Memphis, TN
Classification: Class II
Status: Terminated
Recall initiated: 11 Nov 2019
FDA classified: 17 Dec 2019
Reported: 25 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Hip & Knee Implants

Timeline

11 Nov 2019	Recall initiated by company
17 Dec 2019	Classified by FDA	+36 days
25 Dec 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide

Questions about this recall

Is Profix Mallet recalled?

Yes. Smith & Nephew recalled Profix Mallet on 11 Nov 2019. The recall is Class II and its status is Terminated. Recall number Z-0696-2020.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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