Lower riskMedical device recall · FDA · Published July 1, 2021
DePuy ATTUNE Revision Cemented Stem 16x80mm recalled for incorrect size
DePuy recalls 16x80mm revision cemented knee stem (part 1512-16-080) due to incorrect size in shipment. Affected units may cause improper fit during surgery.
“DePuy ATTUNE Revision Cemented Stem 16x80mm recalled for incorrect size.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62249-depuy-attune-revision-cemented-stem-16x80mm-recalled-for-incorrect-size. Based on FDA recall #Z-2348-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2348-2021%22&limit=1).
DePuy Orthopaedics, Inc. recalled one ATTUNE REVISION CEMENTED STEM unit due to mislabeling, according to the FDA. The agency announced the Class II recall on July 1, 2021.
How to tell if you have it
Brand: DePuy
Product: ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty
Part Number: 1512-16-080
Lot Number: J82N61
Expiry Date: 31May2030
GTIN: 10603295043010
Units affected: 7
The hazard
The package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead, according to the FDA. The record states this results in obtaining a replacement.
Context
GovInfoNow's records show DePuy Orthopaedics, Inc. has 23 other recalls on record since July 12, 2017. Recent similar recalls include the ATTUNE Knee Component recall due to incorrect labeling on March 12, 2024, and the Attune Revision Limb Preservation Tibial Insert recall for radiation dose risk on Feb. 15, 2023.
How to tell if you have this one
Check for part number 1512-16-080 on the packaging. The product was sold with lot number J82N61 and expires May 31, 2030.
Brand
DePuy
Product
ATTUNE REVISION CEMENTED STEM 16X80MM
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the part number on the packaging to confirm it's 1512-16-080.
How this recall unfolded
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2348-2021 (July 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2348-2021 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.