Use caution Medical device recall · FDA · Published December 7, 2021

DePuy Orthopaedics Recall: Global Unite Rev Stem SZ 10 May Cause Surgical Delay

DePuy Orthopaedics recalls Global Unite Rev Stem SZ 10 implants with undersized spigot bore diameter that may require surgical delay or bone damage. Affected units sold globally with specific product code.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0487-2022Medical device DePuy ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmDePuy Orthopaedics, Inc.700 Orthopaedic Dr · Warsaw, IN 46582-3994

✎ GovInfoNow plain-language explainer

DePuy Orthopaedics is recalling its Global Unite Rev Stem SZ 10 hip implants because they may have an undersized spigot bore diameter. This could cause the stem to separate from the hip bone without surgery, potentially requiring additional procedures or causing bone damage. Read more at govinfonow.com/recall/61455-depuy-orthopaedics-recall-global-unite-rev-stem-sz-10-may.

Source Summary by GovInfoNow · govinfonow.com/recall/61455-depuy-orthopaedics-recall-global-unite-rev-stem-sz-10-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0487-2022

Cite this page

“DePuy Orthopaedics Recall: Global Unite Rev Stem SZ 10 May Cause Surgical Delay.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61455-depuy-orthopaedics-recall-global-unite-rev-stem-sz-10-may. Based on FDA recall #Z-0487-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0487-2022%22&limit=1).

The FDA announced on 2021-12-07 that DePuy Orthopaedics, Inc. is recalling GLOBAL UNITE REV STEM SZ 10 implants due to a manufacturing defect. The hazard involves stems with an undersized spigot bore diameter that may prevent separation of the proximal body from the stem without surgical delay or bone damage.

How to tell if you have it

Brand: DePuy
Product: GLOBAL UNITE REV STEM SZ 10
Product Code: 110010600
UPC: 10603295004097
Lot #: 9809673

The hazard

According to the FDA, stems may have an undersized spigot bore diameter. This defect means separating the proximal body from the stem may not be possible without surgical delay and/or bone damage.

Context

GovInfoNow's records show DePuy Orthopaedics, Inc. has 23 other recalls on record since 2017-07-12. Recent brand recalls include the ATTUNE Knee Component recall due to incorrect labeling on 2024-03-12 and the Attune Revision Limb Preservation Tibial Insert recall for radiation dose risk on 2023-02-15. Other recent recalls of similar products include Depuy ATTUNE Revision Hinge Femoral RT SZ 4 CEM (sterility risk) and Depuy ATTUNE Revision Hinge Femoral LT SZ 8 CEM (sterility packaging risk), all announced on 2026-04-03.

How to tell if you have this one

Check for the product code 110010600 on the implant packaging or documentation. The recall covers units sold globally with lot number 9809673 and GTIN 10603295004097.

Brand
DePuy
Product
GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
Category
Medical device

FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
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.

Recall number	Product, codes & lots	Quantity
Z-0483-2022	GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610; Lot #: 9792595, 9793039, 9802121, 9813506. 9818509, 9830922, 9840359,9858603 GTIN: 10603295004011	28 units
Z-0484-2022	GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100; 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	432 units
Z-0485-2022	GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600; Lot #: 9887449 GTIN:10603295004059	3 units
Z-0486-2022	GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100; 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	781 units
Z-0487-2022	GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600; Lot #: 9809673 GTIN: 10603295004097	3 units
Z-0488-2022	GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100; 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	870 units
Z-0489-2022	GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100; 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	451 units
Z-0490-2022	GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100; Lot #: 9793946, 9793947, 9802315, 9802316, 9802317, 9802318, 9802320, 9813856, 9814516, 9824502, 9824503, 9824505, 9834401, 9834402, 9836078, 9841198, 9880972, 9886688, 9887451, 9887452 GTIN: 10603295004189	140 units

Based on the official FDA remedy

What to do — step by step

Check Implant Details
Look for product code 110010600 on the implant packaging or documentation.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

Dec 7, 2021Firm started the recall
Jan 11, 2022FDA classified it Class II
Jan 19, 2022Published in FDA’s Enforcement Report
May 17, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61455-depuy-orthopaedics-recall-global-unite-rev-stem-sz-10-may">DePuy Orthopaedics Recall: Global Unite Rev Stem SZ 10 May Cause Surgical Delay (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0487-2022 (December 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0487-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.