CLASS II Device recall · Reported 4 Sep 2013 · FDA Enforcement Report

Free Lock Femoral Hip Fixation System Compression recalled by Zimmer

Zimmer is recalling Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, distributed nationwide in the US. The recall was initiated on 19 Jun 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes60611049 60624520 60619105 60619109 60624518 60624519 60625544 60619107 60619879 60611045 60624521 60625511 60625536 60625542 60582204 60619887 60657047 60646266 60657046 60657070 60657071 60657072 60632725 60657051 60657073 60657083 60657075 60657078 60657088 60625545 60646267 60657049 60657052 60657077 60657079 60657087 60657084 60668304 60668305 60582089 60674430 60674431 60685115 60714886 60714872 60714893 60714875 60714897 60714851 60714890 60714892 60714850 60714877 60714896 60714891 60714894 60763218 60763232 60763219 60763220 60763221 60763226 60763230 60763234 60763223 60763227 60763229 60763222 60763224 60763225 60763231 60763233 60714895 60763228 60803587 60803589 60803591 60803592 60803593 60807853 60807854 60803588 60803590 60807855 60803586 60807868 60815019 60820809 60841203 60820796 60807857 60820798 60820801 60807858 60807859 60807861 60807856 60815017 60807865 60820810 60820807 60868474 60868478 60874089 60874093 60874097 60877491 60868477 60885177 60885178 60885180 60885182 60885175 60885179 60885185 60885184 60902841 60905697 60902842 60902843 60911345 60911346 60911348 60911350 60931165 60931166 60911349 60931164 60938423 60944574 60931167 60931168 60944606 60932394 60944525 60938427 60944551 60968742 60959978 60969382 60972805 60972806 60968739 60968744 60988403 60988405 60962160 60988402 60988407 60988408 60988404 60998291 60998292 61020344 61030741 61020343 61030740 61037492 61030742 61037493 61037494 61048120 61048117 61048116 61048119 61048115 61048121 61027553 61048118 61027552 61076085 61076086 61086854 61086857 61079836 61079834 61092273 61092280 61101553 61092247 61092249 61092258 61092281 61092283 61101552 61101554 61103203 61103208 61101551 61103202 61103204 61103206 61103207 61108242 61108243 61108244 61115872 61114143 61118976 61140178 61162614 61162616 61162617 61162615 61169420 61198462 61264756 61269944 61198455 61162618 61179754 61179757 61198458 61198460 61198461 61209574 61198456 61209572 61209573 61198457 61264754 61269949 61264753 61198459 61286925 61288126 61294831 61246085 61264748 61286923 61286928 61294832 61294833 61304496 61264749 61264750 61286930 61326116 61264752 61264751 61294834 61341158 61352935 61294835 61352934 61352936 61359996 61359995 61359994 61420344 61420343 61412173 61375175 61436467 61377328 61377330 61379892 61402004 61402005 61402007 61440257 61440688 61375177 61437988 61440689 61457772 61379890 61379891 61437989 61463554 61463555 61440690 61453112 61464380 61457773 61464381 61453111 61463557 61464379 61408293 61473803 61512406 61523582 61523859 61529230 61538716 61542608 61542610 61542611 61558660 61558661 61565485 61565484 61565488 61565486 61565487 61565489 61585377 61578712 61584969 61590989 61590993 61590994 61602063 61613172 61602064 61621833 61628735 61621843 61635176 61621834 61621838 61621842 61640885 61640886 61640887 61700444 61682532 61682545 61672121 61682542 61682544 61682546 61717286 61714071 61719312 61746531 61719308 61719314 61752596 61752594 61752599 61752602 61753041 61761524 61682547 61753042 61753043 61756193 61853082 61870425 61888704 61902191 61990140 62271890 62271887

Quantity recalled85, 794 units in total

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-2091-2013
FDA event ID: 65513
Recalling firm: Zimmer, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 19 Jun 2013
FDA classified: 26 Aug 2013
Reported: 4 Sep 2013
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Hip & Knee Implants

Timeline

19 Jun 2013	Recall initiated by company
26 Aug 2013	Classified by FDA	+68 days
4 Sep 2013	Published in enforcement report	+9 days

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

Reason for recall

Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER Compression Hip Screw , orthopedic implant.

Where it was distributed

Worldwide distribution: US Nationwide (including PR and USVI), and countries of: Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, Beirut, China, Korea, San Salvador, Honduras, Canada, Australia, Switzerland, Germany, Arab Emirates, UK, Belgium, Egypt, Spain, France, Italy, Iran, Lebanon, Jordan, Iraq, Canary Islands.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.

Which lots are affected?

60611049 60624520 60619105 60619109 60624518 60624519 60625544 60619107 60619879 60611045 60624521 60625511 60625536 60625542 60582204 60619887 60657047 60646266 60657046 60657070 60657071 60657072 60632725 60657051 60657073 60657083 60657075 60657078 60657088 60625545 60646267 60657049 60657052 60657077 60657079 60657087 60657084 60668304 60668305 60582089 60674430 60674431 60685115 60714886 60714872 60714893 60714875 60714897 60714851 60714890 60714892 60714850 60714877 60714896 60714891 60714894 60763218 60763232 60763219 60763220 60763221 60763226 60763230 60763234 60763223 60763227 60763229 60763222 60763224 60763225 60763231 60763233 60714895 60763228 60803587 60803589 60803591 60803592 60803593 60807853 60807854 60803588 60803590 60807855 60803586 60807868 60815019 60820809 60841203 60820796 60807857 60820798 60820801 60807858 60807859 60807861 60807856 60815017 60807865 60820810 60820807 60868474 60868478 60874089 60874093 60874097 60877491 60868477 60885177 60885178 60885180 60885182 60885175 60885179 60885185 60885184 60902841 60905697 60902842 60902843 60911345 60911346 60911348 60911350 60931165 60931166 60911349 60931164 60938423 60944574 60931167 60931168 60944606 60932394 60944525 60938427 60944551 60968742 60959978 60969382 60972805 60972806 60968739 60968744 60988403 60988405 60962160 60988402 60988407 60988408 60988404 60998291 60998292 61020344 61030741 61020343 61030740 61037492 61030742 61037493 61037494 61048120 61048117 61048116 61048119 61048115 61048121 61027553 61048118 61027552 61076085 61076086 61086854 61086857 61079836 61079834 61092273 61092280 61101553 61092247 61092249 61092258 61092281 61092283 61101552 61101554 61103203 61103208 61101551 61103202 61103204 61103206 61103207 61108242 61108243 61108244 61115872 61114143 61118976 61140178 61162614 61162616 61162617 61162615 61169420 61198462 61264756 61269944 61198455 61162618 61179754 61179757 61198458 61198460 61198461 61209574 61198456 61209572 61209573 61198457 61264754 61269949 61264753 61198459 61286925 61288126 61294831 61246085 61264748 61286923 61286928 61294832 61294833 61304496 61264749 61264750 61286930 61326116 61264752 61264751 61294834 61341158 61352935 61294835 61352934 61352936 61359996 61359995 61359994 61420344 61420343 61412173 61375175 61436467 61377328 61377330 61379892 61402004 61402005 61402007 61440257 61440688 61375177 61437988 61440689 61457772 61379890 61379891 61437989 61463554 61463555 61440690 61453112 61464380 61457773 61464381 61453111 61463557 61464379 61408293 61473803 61512406 61523582 61523859 61529230 61538716 61542608 61542610 61542611 61558660 61558661 61565485 61565484 61565488 61565486 61565487 61565489 61585377 61578712 61584969 61590989 61590993 61590994 61602063 61613172 61602064 61621833 61628735 61621843 61635176 61621834 61621838 61621842 61640885 61640886 61640887 61700444 61682532 61682545 61672121 61682542 61682544 61682546 61717286 61714071 61719312 61746531 61719308 61719314 61752596 61752594 61752599 61752602 61753041 61761524 61682547 61753042 61753043 61756193 61853082 61870425 61888704 61902191 61990140 62271890 62271887

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

Other products in this recall event

4 other products · FDA event 65513

This product is part of a recall event; the main page for the event is Versa-fx II Femoral Fixation System Compression Tube/Plate recalled.

Reported	Class	Recall	Company	Reason	Where
4 Sep 2013	CLASS II	Versa-fx II Femoral Fixation System Compression Tube/Plate recalled	Zimmer	Sterility	Nationwide
4 Sep 2013	CLASS II	Free Lock Femoral Hip Fixation System Compression Lag Screw recalled	Zimmer	Sterility	Nationwide
4 Sep 2013	CLASS II	Versa-fx II Femoral Fixation System Compression Tube/Plate recalled	Zimmer	Sterility	Nationwide
4 Sep 2013	CLASS II	Versa-fx Femoral Fixation System Compression Lag Screw recalled	Zimmer	Sterility	Nationwide

More recalls from Zimmer

All 539

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Device	CLASS II	Off-Axis Comprehensive Shoulder System, Large, Augment recalled	Zimmer	Foreign Material	Nationwide
1 Jul 2026Device	CLASS II	Off-Axis Comprehensive Shoulder System Small, Augment recalled by Zimmer	Zimmer	Foreign Material	Nationwide
1 Jul 2026Device	CLASS II	Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide recalled	Zimmer	Foreign Material	Nationwide
1 Jul 2026Device	CLASS II	Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment recalled	Zimmer	Packaging Defects	IN
1 Jul 2026Device	CLASS II	Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide recalled	Zimmer	Foreign Material	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide