DePuy Orthopaedics recalls Global Unite STD Stem SZ 16 product code 110016100 with specific lot numbers. Stems may separate improperly causing surgical delays or bone damage. Consumers should contact DePuy for details.
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
DePuy Orthopaedics is recalling its Global Unite STD Stem SZ 16 product due to a risk that the stem may not connect properly, potentially requiring surgery or causing bone damage. This affects patients using the implant in their hip or knee replacements.
The stems may have an undersized spigot bore diameter, which can prevent the stem from securely attaching to the proximal body. This could lead to the stem becoming loose or separating during use, requiring additional surgery or causing bone damage.
Patients who have received the Global Unite STD Stem SZ 16 implant (product code 110016100) are most at risk. This recall applies to individuals with hip or knee replacements using the specific lot numbers listed.
Check the product code on the implant (110016100) and the lot numbers listed: 9793946, 9793947, 9802315, 9802316, 9802317, 9802318, 9802320, 9813856, 9814516, 9824502, 9824503, 9824505, 9834401, 9834402, 9836078, 9841198, 9880972, 9886688, 9887451, 9887452.
Reach out to DePuy Orthopaedics directly for guidance on the recall and next steps.
The product code is 110016100.
The affected lot numbers are 9793946, 9793947, 9802315, 9802316, 9802317, 9802318, 9802320, 9813856, 9814516, 9824502, 9824503, 9824505, 9834401, 9834402, 9836078, 9841198, 9880972, 9886688, 9887451, 9887452.
The stems may have an undersized spigot bore diameter, which can prevent the stem from securely attaching to the proximal body, potentially requiring additional surgery or causing bone damage.
We’ve drafted a message you can send DePuy to request your refund or repair — edit it as you like.
Subject: Recall Z-0490-2022 — DePuy DePuy Hello, I own a DePuy that is covered by recall Z-0490-2022 from DePuy. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
