Unrated Medical device recall · FDA · Published January 29, 2018

Encore Medical Altivate Anatomic Shoulder Implant Recall: Design Flaw Risk

Encore Medical recalls Altivate Anatomic Shoulder Implants (size 50mm) due to a design flaw where pegs may not align properly with implants during surgery, potentially causing complications. Affected units include specific part numbers.

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

🇺🇸 FDA recall #Z-1259-2018Medical device Encore Medical ›

Recall notice

It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants

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Contact the company

Recalling firmEncore Medical, Lp9800 Metric Blvd · Austin, TX 78758-5445

✎ GovInfoNow plain-language explainer

Encore Medical is recalling certain Altivate Anatomic shoulder implants (size 50mm) because the pegs at the base of the implants are designed to be larger than the implants themselves. This could cause misalignment during surgery, leading to potential complications for patients. Read more at govinfonow.com/recall/72080-encore-medical-altivate-anatomic-shoulder-implant-recall-design-flaw-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/72080-encore-medical-altivate-anatomic-shoulder-implant-recall-design-flaw-risk · Updated August 31, 2026 · FDA enforcement record: FDA #Z-1259-2018

Cite this page

“Encore Medical Altivate Anatomic Shoulder Implant Recall: Design Flaw Risk.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72080-encore-medical-altivate-anatomic-shoulder-implant-recall-design-flaw-risk. Based on FDA recall #Z-1259-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1259-2018%22&limit=1).

Encore Medical, LP voluntarily recalled Altivate Anatomic(TM) Instrumentation, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 due to a design hazard, the FDA said on Jan. 29, 2018.

How to tell if you have it

Brand: Encore Medical
Product: Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm
REF: 804-07-500
Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540
Units: 92

The hazard

The FDA said the radius at the base of the pegs of the Anatomic Glenoid Trial is much larger on the trials than on the implants. This design discrepancy was discovered during a surgery.

Context

GovInfoNow's records show Encore Medical, LP has 43 other recalls on record since May 31, 2017. Recent brand recalls include an EMPOWR 3D KNEE Ins 11L 14MM VE packaging mix-up (Feb. 16, 2026) and incorrect labeling for EMPOWR 3D KNEE Implants (Jan. 15, 2026). Other recent recalls of similar products include U2 Total Knee System Femoral Offset Bushing Recall (March 19, 2026), Straumann Bone Level Tapered Implant May Be Wrong Length - Recall (July 16, 2026), and Howmedica DURACON XL Angled Tibial Implants Recall: Risk of Wear Debris and Revision Surgery (July 30, 2026).

How to tell if you have this one

Check if your implant has part numbers 804-07-380, 804-07-420, 804-07-460, 804-07-500, or 804-07-540. The product is used in shoulder replacement surgeries and is labeled as the Altivate Anatomic Shoulder System.

Brand
Encore Medical
Category
Medical device

FDA recall event · 5 products

All 5 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
Completed
Distribution
US Nationwide Distribution

Recall number	Product, codes & lots	Quantity
Z-1256-2018	Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.; All Serial Numbers	92 units
Z-1257-2018	Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.; All Serial Numbers	92 units
Z-1258-2018	Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.; All Serial Numbers	92 units
Z-1259-2018	Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.; All Serial Numbers	92 units
Z-1260-2018	Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.; All Serial Numbers	93 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the part numbers on your implant to confirm if it is affected (804-07-380 to 804-07-540).

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

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

Jan 29, 2018Firm started the recall
Mar 28, 2018FDA classified it Class II
Apr 4, 2018Published in FDA’s Enforcement Report

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/72080-encore-medical-altivate-anatomic-shoulder-implant-recall-design-flaw-risk">Encore Medical Altivate Anatomic Shoulder Implant Recall: Design Flaw Risk (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-1259-2018 (January 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1259-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 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.