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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89240

8 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 07, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DePuy Orthopaedics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 8

GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610

Z-0483-2022
Recall number
Z-0483-2022
Initiated
December 07, 2021
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
28 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

Code information

Lot #: 9792595, 9793039, 9802121, 9813506. 9818509, 9830922, 9840359,9858603 GTIN: 10603295004011

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.

device · product 2 of 8

GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100

Z-0484-2022
Recall number
Z-0484-2022
Initiated
December 07, 2021
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
432 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

Code information

Lot # s 9793035, 9802134, 9802135, 9802136, 9802137, 9802138, 9802139, 9802140, 9802141, 9802142, 9802143, 9802144, 9802145, 9802146, 9802147, 9802148, 9802149, 9802150, 9802151, 9814515, 9817165, 9817166, 9817167, 9817168, 9817633, 9818331, 9824332, 9824334, 9824335, 9824336, 9824337, 9824338, 9824339, 9824340, 9824341, 9824342, 9824343, 9824344, 9824345, 9824346, 9824347, 9832804, 9851705, 9851706, 9851707, 9851708, 9862057, 9864147, 9874672, 9874674, 9874675, 9874676, 9874678, 9874682, 9874683, 9874686, 9874688, 9887446 GTIN: 10603295004042

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.

device · product 3 of 8

GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600

Z-0485-2022
Recall number
Z-0485-2022
Initiated
December 07, 2021
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

Code information

Lot #: 9887449 GTIN:10603295004059

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.

device · product 4 of 8

GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100

Z-0486-2022
Recall number
Z-0486-2022
Initiated
December 07, 2021
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
781 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

Code information

Lot #: 9793653, 9802160, 9802161, 9802162, 9802163, 9802164, 9802165, 9802166, 9802167, 9802168, 9802169, 9802170, 9802171, 9802172, 9802173, 9802174, 9802175, 9802176, 9802177, 9802178, 9802179, 9802180, 9802181, 9802182, 9802183, 9802184, 9802185, 9802186, 9802187, 9802188, 9802189, 9802190, 9802191, 9818345, 9824373, 9824374, 9824375, 9824376, 9824377, 9824378, 9824379, 9824380, 9824381, 9824382, 9824383, 9824384, 9824385, 9824386, 9824387, 9824388, 9824389, 9824390, 9824391, 9824392, 9824393, 9824394, 9824395, 9824398, 9824399, 9824400, 9824401, 9824402, 9824403, 9832827, 9841211, 9841212, 9842708, 9842709, 9842710, 9842711, 9843084, 9851725, 9851727, 9851728, 9851729, 9851730, 9851731, 9851732, 9851733, 9851734, 9851736, 9851739, 9851742, 9851743, 9851744, 9864146, 9874719, 9874720, 9874721, 9874722, 9874724, 9874726, 9874727, 9874728, 9874729, 9874733, 9874739, 9874744 GTIN: 10603295004080

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.

device · product 5 of 8

GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600

Z-0487-2022
Recall number
Z-0487-2022
Initiated
December 07, 2021
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

Code information

Lot #: 9809673 GTIN: 10603295004097

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.

device · product 6 of 8

GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100

Z-0488-2022
Recall number
Z-0488-2022
Initiated
December 07, 2021
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
870 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

Code information

Lot #: 9793650, 9793651, 9793652, 9802212, 9802213, 9802214, 9802215, 9802216, 9802217, 9802218, 9802219, 9802220, 9802221, 9802222, 9802223, 9802224, 9802225, 9802226, 9802227, 9802228, 9802229, 9802230, 9802231, 9802232, 9802233, 9802234, 9802235, 9802236, 9802237, 9802238, 9802239, 9802240, 9802241, 9802242, 9802243, 9802244, 9802245, 9802246, 9802249, 9802250, 9802251, 9802253, 9802254, 9802255, 9802256, 9802257, 9802258, 9802259, 9824440, 9824441, 9824442, 9824443, 9824445, 9824446, 9824447, 9824448, 9824449, 9824450, 9824451, 9824457, 9824458, 9824459, 9824461, 9824462, 9824463, 9824464, 9824465, 9824466, 9824467, 9824468, 9824469, 9824470, 9824471, 9824472, 9824473, 9824474, 9824475, 9851771, 9851772, 9851774, 9851775, 9851776, 9851777, 9851779, 9851780, 9851781, 9851784, 9851786, 9851787, 9851790, 9851791, 9851796, 9851799, 9851801, 9851802, 9851803, 9851804, 9851807, 9851809, 9874795, 9874796, 9874798, 9874799, 9874800, 9874801, 9874802, 9874803, 9874808, 9874809, 9874811, 9874826, 9874829, 9874831 GTIN: 10603295004127

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.

device · product 7 of 8

GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100

Z-0489-2022
Recall number
Z-0489-2022
Initiated
December 07, 2021
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
451 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

Code information

Lot#: 9792322, 9792323, 9793656, 9793942, 9793943, 9802283, 9802284, 9802285, 9802286, 9802287, 9802288, 9802289, 9802290, 9802291, 9802292, 9802293, 9802294, 9802295, 9802296, 9802297, 9802298, 9802299, 9802300, 9802301, 9802302, 9802306, 9802307, 9802308, 9802309, 9824482, 9824484, 9824485, 9824486, 9824487, 9824488, 9824489, 9824490, 9824491, 9824492, 9824493, 9824494, 9824495, 9824496, 9832814, 9832815, 9832816, 9832828, 9841207, 9851826, 9851828, 9851830, 9851831, 9851833, 9851834, 9851835, 9851839, 9851840, 9885297, 9897488, 9897491 GTIN: 10603295004158

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.

device · product 8 of 8

GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100

Z-0490-2022
Recall number
Z-0490-2022
Initiated
December 07, 2021
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
140 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

Code information

Lot #: 9793946, 9793947, 9802315, 9802316, 9802317, 9802318, 9802320, 9813856, 9814516, 9824502, 9824503, 9824505, 9834401, 9834402, 9836078, 9841198, 9880972, 9886688, 9887451, 9887452 GTIN: 10603295004189

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.