Z-0486-2022Class II

GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100

Name: Z-0486-2022 GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
Creator: DePuy Orthopaedics, Inc.
Published: 2021-12-07
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2021-12-07 / Terminated / root cause: manufacturing process

FDA source

DePuy Orthopaedics, Inc. began a recall of GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100 on 2021-12-07. FDA classified it as Class II and gives the reason as "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". 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-0486-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-07
Posted: 2022-01-11
Terminated: 2024-05-17
Recalling firm: Depuy Orthopaedics Inc.
Product: GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
Product code: PHX Shoulder Prosthesis, Reverse Configuration
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
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: DePuy notified US hospital / government consignees on 12/7/21 letter Urgent Medical Device Recall (Removal) via the sales consult and product will be removed/notice delivered by hand or if not able to enter facility the form will be emailed and returns will be arranged. US sales/distributor offices will be notified via email. Affiliates outside of the US affiliates will be notified via the electronic system and recall activities will be carried out per local regulations. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have the select lots and quarantine the product. 2. Return the subject product(s) using the normal returns process. Work with your sales consultant to return subject product(s). To receive replacement product(s) or reimbursement, customers must return the products subject to this removal. 3. Review, complete all fields, sign, and return the attached business response form (BRF) on the last page of this letter to [email protected] within three (3) business days of receipt of this Removal Letter. Please include in the email subject: FA 2044436 - 2021 GLOBAL UNITE Stems with undersized Spigot Bore Diameter. 4. Forward this Removal Letter to any personnel in your facility who need to be informed. 5. If any of the product(s) subject to this Removal have been forwarded to another facility, contact that facility and provide a copy of this Removal Letter to the relevant personnel. 6. Post a copy of this Removal Letter in a visible area for awareness of this Removal. If you have any questions, please contact your local DePuy Synthes Sales Consultant. For Medical Information request, please visit our website: https://www.jnjmedicaldevices.com/mir.
Quantity in commerce: 781 units
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0486-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0483-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-19	2022-01-11
Z-0484-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-19	2022-01-11
Z-0485-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-19	2022-01-11
Z-0486-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-19	2022-01-11
Z-0487-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-19	2022-01-11
Z-0488-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-19	2022-01-11
Z-0489-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-19	2022-01-11
Z-0490-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-19	2022-01-11

Product code PHX

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)