Lower risk Medical device recall · FDA · Published June 28, 2021

Encore Medical AltiVate Shoulder System Recall: Humeral Stem Failing to Mate

Encore Medical recalls AltiVate Anatomic Shoulder System parts due to humeral stem failing to mate with broach handles, potentially causing procedure delays or revision surgery.

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

🇺🇸 FDA recall #Z-2331-2021Medical device Encore Medical ›

Lower-risk recall

Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery.

Take action

Contact the company

Recalling firmEncore Medical, LP9800 Metric Blvd · Austin, TX 78758-5445

✎ GovInfoNow plain-language explainer

Encore Medical is recalling specific parts of their AltiVate Anatomic Shoulder System because the humeral stem may not properly connect with the broach handles. This could lead to surgery delays or the need for additional procedures. Read more at govinfonow.com/recall/62298-encore-medical-altivate-shoulder-system-recall-humeral-stem-failing-to.

Source Summary by GovInfoNow · govinfonow.com/recall/62298-encore-medical-altivate-shoulder-system-recall-humeral-stem-failing-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2331-2021

Cite this page

“Encore Medical AltiVate Shoulder System Recall: Humeral Stem Failing to Mate.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62298-encore-medical-altivate-shoulder-system-recall-humeral-stem-failing-to. Based on FDA recall #Z-2331-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2331-2021%22&limit=1).

The FDA announced on June 28, 2021, that Encore Medical, LP is recalling the AltiVate Anatomic Shoulder System due to a hazard where the humeral stem may fail to mate with broach handles. This defect could result in procedure delays or revision surgery.

How to tell if you have it

Brand: Encore Medical
Product: AltiVate Anatomic Shoulder System
Part # 520-08-00, Rev. C.
Part # 520-10-000
Part # 520-12-000
Part # 520-14-000
Part # 520-16-000
Lot numbers: 85OU1108; 85OU1110; 85OU1111; 851U1256; 851U1257; 851U1258; 851U1259; 852U1402; 852U1393; 852U1404; 852U1395; 852U1398A; 852U1405; 852U1397; 852U1391; 852U1400; 852U1398; 852U1407; 852U1396; 852U1406; 853U1234; 853U1240; 853U1241A; 853U1238; 853U1239; 853U1237; 853U1241; 854U1076; 854U1077

The hazard

According to the FDA, complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery.

Context

GovInfoNow's records show Encore Medical, LP has had 43 other recalls on record since May 31, 2017. Other recent recalls include the EMPOWR 3D Knee Tibial Insert 5R 14MM Recall (Jan. 5, 2026), the RSP Humeral Socket Insert Recall (Jan. 15, 2026), and the EMPOWR 3D KNEE Ins 11L 14MM VE Packaging Mix-Up Recall (Feb. 16, 2026). Other recent recalls of similar products include the Zimmer Off-Axis Shoulder System Recalled Due to Plastic Guide Breakage (May 20, 2026) and the Merit Medical Custom Manifold Kit Recall (Dec. 4, 2025).

How to tell if you have this one

Check if your AltiVate Anatomic Shoulder System includes part numbers 520-08-00 (Rev. C), 520-10-000, 520-12-000, 520-14-000, or 520-16-000 with specific lot numbers listed in the recall notice.

Brand
Encore Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Part Numbers
Identify if your AltiVate Anatomic Shoulder System includes part numbers 520-08-00 (Rev. C), 520-10-000, 520-12-000, 520-14-000, or 520-16-000 with the listed lot numbers.

Where it went and when

Where it was distributed

Distributed in 34 states and Puerto Rico.

FDA distribution: “US: AL,AR,AZ,CA,CO,FL,GA,HI,IL,IN,KY,LA,MD,ME,MI,MN,MO,MS,MT,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,TN,TX,UT,VA,WA,WV OUS: N/A” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia.

Recall timeline

FDA published this recall 2 months after the firm started it.

Jun 28, 2021Firm started the recall
Aug 23, 2021FDA classified it Class II
Sep 1, 2021Published in FDA’s Enforcement Report

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

Similar recalls

Latest medical device recalls

Keep exploring

More Encore Medical recalls

Link to this recall

<a href="https://govinfonow.com/recall/62298-encore-medical-altivate-shoulder-system-recall-humeral-stem-failing-to">Encore Medical AltiVate Shoulder System Recall: Humeral Stem Failing to Mate (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-2331-2021 (June 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2331-2021 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.