Z-2299-2018Class II

LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236

Name: Z-2299-2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236
Creator: Howmedica Osteonics Corp.
Published: 2018-05-22
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2018-05-22 / Terminated / root cause: manufacturing process

FDA source

Howmedica Osteonics Corp. began a recall of LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236 on 2018-05-22. FDA classified it as Class II and gives the reason as "The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2299-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-22
Posted: 2018-10-11
Terminated: 2020-05-08
Recalling firm: Howmedica Osteonics Corp
Product: LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On May 22, 2018, Stryker issued a Product Safety Notification to its affected customers. The letter explained the issue and instructed customers to do the following: Follow-up Patients implanted with the Products should continue to be followed per the normal protocol established by his/her surgeon(s). There are no recommended changes to the frequency of the standard follow-up care protocol. Required actions 1. Hospitals/Surgeons: Please inform product users of this notification and forward this notice to all those individuals who need to be aware within your organization. Please also complete and sign the enclosed Business Reply Form and fax a copy to 888-861-8582 or email to Stericycle at strykerortho5940@stencycle com. Product is not required to be returned as part of this notification. if you have any questions, feel free to contact the firm at (201) 831-5151.
Distribution: Distributed nationwide. Foreign distribution to Australia, Canada, Chile, China, Brazil, France, Germany, India, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Portugal, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
Product codes and lots: Lots MJHT6N MJHT6T MJK94R MJKAX5 MJKD54 MJKDA6 MJKDD0 MJKDV5 MJKDV7 MJKDV8 MJKE0N MJKE2L MJKE2M MJKE2N MJKEEV MJKEEW MJKEEY MJKH03 MJKH4W MJKHM4 MJKHM6 MJKHM7 MJKHPT MJKHPW MJKHPX MJKHWJ MJKHXJ MJKJ13 MJKRM4 MJKRNN MJKRT7 MJKT2V MJKTPT MJKTYW MJKV11 MJKV22 MJKVMV MJKVNH MJKVPL MJKVWJ MJKW33 MJM046 MJM0A8 MJM0P9 MJM0WP MJM194 MJM26Y MJM27P MJM2P5 MJM2WT MJM323 MJM33W MJM3HN MJM3NA MJRAKL MJRANR MJRE1T MJRED7 MJREPY MJRH3T MJRH70 MJRH8H MJRHEX MJRJ37 MJRJ60 MJRJ9M MJRJLY MJRJMM MJRK2P MJRKEN MJRKW3 MJRMVA MJRNHN MJRR3N MJRTJ2 MJRTP7 MJRVH0 MJRVMM MJRW0K MJRW87 MJRX01 MJRYMD MJT03J MJT0XL MJT2PD MJT2RP MJT3L3 MJT53H MJT546 MJT5RX MJT6PK MJT6Y3 MJT7DY MJT7RN MJT7V9 MJT8LR MJTEDK MJTEVE MJTHAX MJTHT7 MJTHVP MJTJDA MJTKKM MJTL0N MJTLE6 MJTLR5 MJTMP7 MJTMY5 MJTN0T MJTP1R MJTP4D MJTPE2 MJTR46 MJTRA8 MJTRAP MJTRY7 MJTTKL MJTTT3 MJTV44 MJTVEV MJTVNK MJTVRE MJTVRJ MJTVY8 MJTW5E MJM47Y MJM4LY MJM4ND MJM4PD MJM4T9 MJM55P MJM5L8 MJM64Y MJM694 MJM6H2 MJM79R MJM7J8 MJM7Y0 MJM82Y MJM88K MJM89W MJM8X6 MJM945 MJM949 MJM951 MJM9D0 MJMA3V MJMAJ8 MJMAP5 MJMAYR MJMDA2 MJMEA1 MJMEEA MJMEK2 MJMH49 MJMHN7 MJMHN9 MJMHXT MJMJRP MJMKHY MJMKRE MJML01 MJML7X MJMLR1 MJMM3M MJMMLD MJMMVE MJMMX9 MJMMYJ MJMN7P MJMN8T MJMP7R MJMPKA MJMPP6 MJMR8L MJMRW9 MJMT5P MJMT60 MJMTA3 MJTWD8 MJTX6W MJTX7K MJTY26 MJTY9Y MJTYL0 MJTYWX MKA03J MKA06L MKA0AD MKA120 MKA1N4 MKA2V9 MKA3A9 MKA45W MKA4X4 MKA500 MKA54D MKA5T2 MKA6E8 MKA714 MKA76T MKA892 MKA903 MKA972 MKA98X MKA9A5 MKAA45 MKAD0V MKAD3R MKADKW MKADL8 MKAE41 MKAJ1X MKAK79 MKAKRT MKAKV5 MKAL93 MKAM4V MKAN2L MKAN56 MKAP39 MKAR0X MKAR81 MKARWR MKAVMR MKAXT9 MKAXYV MKAYWV MKD01T MKD05N MKD0DA MKD0N3 MKD12W MKD1R8 MKD265 MKD2AA MKD3MX MKD3PK MKD456 MKD4AR MKD4NE MKD4XE MKD51M MKD59R MKD5R5 MKD5W8 MKD63H MKD6TR MKD6WT MKD7AR MJMTMY MJMTYV MJMV2V MJMV52 MJMV5A MJMVNE MJMVTP MJMW5L MJMWA0 MJMWHT MJMWK8 MJMWMT MJMX3A MJMX85 MJMXDW MJMXLK MJMXLY MJMY7K MJMYKN MJN05N MJN068 MJN0V5 MJN1RN MJN2DH MJN2XJ MJN3AN MJN3PE MJN40J MJN55J MJN79A MJN8NA MJN93P MJN9N6 MJNA0R MJNAL2 MJND4P MJND9V MJNDN5 MJNDV5 MJNDYM MJNJAE MJNJAJ MJNL7A MJNLW5 MJNM1M MJNN1D MJNR0Y MJNR8T MJNRK2 MJNRRT MJNT2N MJNT58 MJNV8J MJNVER MKD7L7 MKD853 MKD8EA MKD8P5 MKD8PM MKDA3L MKDA3T MKDDW8 MKDE3P MKDE9A MKDH0W MKDHP9 MKDJ8W MKDJXJ MKDKNY MKDKWK MKDLM3 MKDMP7 MKDN29 MKDNR0 MKDNTM MKDP9T MKDPDV MKDPET MKDTV3 MKDV0L MKDVT7 MKDX1Y MKDYRR MKE0HM MKE1T3 MKED81 MKEEJD MKEH33 MKELEP MKEM2W MKEN5V MKEPWW MKEY8M MJNVPY MJNW49 MJNWA2 MJNWH5 MJNYLP MJP0VH MJP0XW MJP1L6 MJP1N1 MJP22P MJP2MD MJP335 MJP35R MJP3V2 MJP41T MJP4NV MJP4X6 MJP52E MJP5NW MJP7ED MJP8A8 MJP8P7 MJP8YH MJP92J MJPAAX MJPANN MJPD55 MJPE4P MJPE5R MJPEX0 MJPJ4D MJPJH2 MJPJM8 MJPKW0 MJPL39 MJPL3L MJPM47 MJPMA7 MJPMKX MJPN77 MJPP4Y MJPR1H MJPR5E MJPTV3 MJPTWT MJPVM3 MJPVMM MJPWH1 MJPWHV MJPX1M MJPY8M MJPYK3 MJPYMX MJR02N MJR1K0 MJR1PA MJR27K MJR2V1 MJR4K2 MJR5J0 MJR5TM MJR68L MJR7DL MJR7XX MJR859 MJR8X6 MJR8YL MJR95L MJR9DM MJR9KY MJR9X3 MJRA2V

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2299-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2292-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-02
Z-2293-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-02
Z-2294-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-02
Z-2295-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-02
Z-2296-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-02
Z-2297-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-02
Z-2298-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-02
Z-2299-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-02

Product code JDI

K022077Class II36Mm V40 Femoral Head Components (Lfit and Non-Lfit)Howmedica Osteonics Corp. / cleared 2002-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)