FDA Device recall Z-1141-2016

Product 43 consists of all product under product code: HSB and same usage: Item no: 224001016 M/DN R-F IM NAIL 10MM DIA 224001018 M/DN R-F…

FDA Device
Class II
terminated
Published 2016-03-23

On 2016-03-23 the FDA classified a Class II recall of Product 43 consists of all product under product code: HSB and same usage: Item no: 224001016 M/DN R-F IM NAIL 10MM DIA 224001018 M/DN R-F… by Zimmer Manufacturing B V, citing as a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1141-2016
Classification	Class II
Status	terminated
Initiated	2016-01-11
Published	2016-03-23
Last updated	2026-09-13 11:54 UTC
Company	Zimmer Manufacturing B V
Distribution	US

Product

Product 43 consists of all product under product code: HSB and same usage: Item no: 224001016 M/DN R-F IM NAIL 10MM DIA 224001018 M/DN R-F IM NAIL 10MM DIA 224001020 M/DN R-F IM NAIL 10MM DIA 224001022 M/DN R-F IM NAIL 10MM DIA 224001024 M/DN R-F IM NAIL 10MM DIA 224001026 M/DN R-F IM NAIL 10MM DIA 224001028 M/DN R-F IM NAIL 10MM DIA 224001030 M/DN R-F IM NAIL 10MM DIA 224001032 M/DN R-F IM NAIL 10MM DIA 224001034 M/DN R-F IM NAIL 10MM DIA 224001036 M/DN R-F IM NAIL 10MM DIA 224001038 M/DN R-F IM NAIL 10MM DIA 224001040 M/DN R-F IM NAIL 10MM DIA 224001042 M/DN R-F IM NAIL 10MM DIA 224001114 M/DN R-F IM NAIL 11MM DIA 224001116 M/DN R-F IM NAIL 11MM DIA 224001118 M/DN R-F IM NAIL 11MM DIA 224001120 M/DN R-F IM NAIL 11MM DIA 224001122 M/DN R-F IM NAIL 11MM DIA 224001124 M/DN R-F IM NAIL 11MM DIA 224001126 M/DN R-F IM NAIL 11MM DIA 224001128 M/DN R-F IM NAIL 11MM DIA 224001130 M/DN R-F IM NAIL 11MM DIA 224001132 M/DN R-F IM NAIL 11MM DIA 224001134 M/DN R-F IM NAIL 11MM DIA 224001136 M/DN R-F IM NAIL 11MM DIA 224001138 M/DN R-F IM NAIL 11MM DIA 224001140 M/DN R-F IM NAIL 11MM DIA 224001142 M/DN R-F IM NAIL 11MM DIA 224001144 M/DN R-F IM NAIL 11MM DIA 224001146 M/DN R-F IM NAIL 11MM DIA 224001218 M/DN R-F IM NAIL 12MM DIA 224001220 M/DN R-F IM NAIL 12MM DIA 224001224 M/DN R-F IM NAIL 12MM DIA 224001226 M/DN R-F IM NAIL 12MM DIA 224001228 M/DN R-F IM NAIL 12MM DIA 224001230 M/DN R-F IM NAIL 12MM DIA 224001232 M/DN R-F IM NAIL 12MM DIA 224001234 M/DN R-F IM NAIL 12MM DIA 224001236 M/DN R-F IM NAIL 12MM DIA 224001238 M/DN R-F IM NAIL 12MM DIA 224001240 M/DN R-F IM NAIL 12MM DIA 224001242 M/DN R-F IM NAIL 12MM DIA 224001244 M/DN R-F IM NAIL 12MM DIA 224001248 M/DN R-F IM NAIL 12MM DIA 224001318 M/DN R-F IM NAIL 13MM DIA 224001324 M/DN R-F IM NAIL 13MM DIA 224001326 M/DN R-F IM NAIL 13MM DIA 224001328 M/DN R-F IM NAIL 13MM DIA 224001330 M/DN R-F IM NAIL 13MM DIA 224001332 M/DN R-F IM NAIL 13MM DIA 224001334 M/DN R-F IM NAIL 13MM DIA 224001336 M/DN R-F IM NAIL 13MM DIA 224001338 M/DN R-F IM NAIL 13MM DIA 224001340 M/DN R-F IM NAIL 13MM DIA 224001344 M/DN R-F IM NAIL 13MM DIA 224001346 M/DN R-F IM NAIL 13MM DIA 224001348 M/DN R-F IM NAIL 13MM DIA 224001422 M/DN R-F IM NAIL 14MM DIA 224001436 M/DN R-F IM NAIL 14MM DIA 224001438 M/DN R-F IM NAIL 14MM DIA 224001440 M/DN R-F IM NAIL 14MM DIA 224001442 M/DN R-F IM NAIL 14MM DIA 224001444 M/DN R-F IM NAIL 14MM DIA 224001446 M/DN R-F IM NAIL 14MM DIA 224000922 M/DN R-F IM NAIL 9MM DIA 224000926 M/DN R-F IM NAIL 9MM DIA 224000928 M/DN R-F IM NAIL 9MM DIA 224000930 M/DN R-F IM NAIL 9MM DIA 224000932 M/DN R-F IM NAIL 9MM DIA 224000934 M/DN R-F IM NAIL 9MM DIA 224000936 M/DN R-F IM NAIL 9MM DIA 224000942 M/DN R-F IM NAIL 9MM DIA 224000946 M/DN R-F IM NAIL 9MM DIA 225320010 M/DN TIBIAL I/M NAIL 10MM 225326010 M/DN TIBIAL I/M NAIL 10MM 225328010 M/DN TIBIAL I/M NAIL 10MM 225330010 M/DN TIBIAL I/M NAIL 10MM 225332010 M/DN TIBIAL I/M NAIL 10MM 225334010 M/DN TIBIAL I/M NAIL 10MM 225336010 M/DN TIBIAL I/M NAIL 10MM 225338010 M/DN TIBIAL I/M NAIL 10MM 225344010 M/DN TIBIAL I/M NAIL 10MM 225320011 M/DN TIBIAL I/M NAIL 11MM 225322011 M/DN TIBIAL I/M NAIL 11MM 225324011 M/DN TIBIAL I/M NAIL 11MM 225326011 M/DN TIBIAL I/M NAIL 11MM 225328011 M/DN TIBIAL I/M NAIL 11MM 225330011 M/DN TIBIAL I/M NAIL 11MM 225332011 M/DN TIBIAL I/M NAIL 11MM 225334011 M/DN TIBIAL I/M NAIL 11MM 225336011 M/DN TIBIAL I/M NAIL 11MM 225338011 M/DN TIBIAL I/M NAIL 11MM 225340011 M/DN TIBIAL I/M NAIL 11MM 225342011 M/DN TIBIAL I/M NAIL 11MM 225344011 M/DN TIBIAL I/M NAIL 11MM 225346011 M/DN TIBIAL I/M NAIL 11MM 225328012 M/DN TIBIAL I/M NAIL 12MM 225330012 M/DN TIBIAL I/M NAIL 12MM 225332012 M/DN TIBIAL I/M NAIL 12MM 225334012 M/DN TIBIAL I/M NAIL 12MM 225336012 M/DN TIBIAL I/M NAIL 12MM 225338012 M/DN TIBIAL I/M NAIL 12MM 225340012 M/DN TIBIAL I/M NAIL 12MM 225346012 M/DN TIBIAL I/M NAIL 12MM 225324013 M/DN TIBIAL I/M NAIL 13MM

Reason

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Identifiers

code_info	lot no.: 370673 370503 61929690 61929695 370525 370502 61775812 61815339 61836513 370524 62031813 61815340… lot no.: 370673 370503 61929690 61929695 370525 370502 61775812 61815339 61836513 370524 62031813 61815340 61986781 62027941 62041736 62296539 370522 37107460 61986656 62031814 62296541 62304916 62337080 370666 371030 61794154 62137460 62142342 62300946 370672 37107637 61988381 62310758 62337085 370521 62019015 62337075 370671 371026 37107402 62255925 62300951 370567 37107452 370670 370527 371028 37107454 62255930 370699 61850299 62009791 62310760 370536 370596 61775816 62025367 62291092 62304917 37107456 61986657 62019062 62271634 62296587 371040 62019072 62255933 370594 61940056 62019117 62272160 370592 371027 37107403 61940058 62031817 62248168 62291094 62300957 370675 371031 37107445 61775814 61836514 62255940 62304919 370535 37107638 62025375 62293097 370678 370677 370676 370600 61621133 370679 37107451 62291097 62025380 370501 61780307 370500 370534 62304921 61929772 37107640

code_info

lot no.: 370673 370503 61929690 61929695 370525 370502 61775812 61815339 61836513 370524 62031813 61815340…

lot no.: 370673 370503 61929690 61929695 370525 370502 61775812 61815339 61836513 370524 62031813 61815340 61986781 62027941 62041736 62296539 370522 37107460 61986656 62031814 62296541 62304916 62337080 370666 371030 61794154 62137460 62142342 62300946 370672 37107637 61988381 62310758 62337085 370521 62019015 62337075 370671 371026 37107402 62255925 62300951 370567 37107452 370670 370527 371028 37107454 62255930 370699 61850299 62009791 62310760 370536 370596 61775816 62025367 62291092 62304917 37107456 61986657 62019062 62271634 62296587 371040 62019072 62255933 370594 61940056 62019117 62272160 370592 371027 37107403 61940058 62031817 62248168 62291094 62300957 370675 371031 37107445 61775814 61836514 62255940 62304919 370535 37107638 62025375 62293097 370678 370677 370676 370600 61621133 370679 37107451 62291097 62025380 370501 61780307 370500 370534 62304921 61929772 37107640

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1141-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.