Use cautionMedical device recall · FDA · Published January 30, 2018
Encore Medical AltiVate Humeral Socket Shell Trial Recall: Broken Screws Risk Injury
Encore Medical recalls AltiVate Humeral Socket Shell Trial (REF 803-06-152) due to broken screws and retaining clips that may cause injury during surgery.
“Encore Medical AltiVate Humeral Socket Shell Trial Recall: Broken Screws Risk Injury.” GovInfoNow, updated August 28, 2026. https://govinfonow.com/recall/72078-encore-medical-altivate-humeral-socket-shell-trial-recall-broken-screws. Based on FDA recall #Z-1241-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1241-2018%22&limit=1).
Encore Medical, LP voluntarily recalled AltiVate Reverse Instrumentation humeral socket shell trials on Jan. 30, 2018, according to the FDA. The devices pose a hazard of broken or missing screws and retaining clips due to screw tolerance and material strength issues.
How to tell if you have it
Brand: Encore Medical
Product: AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD
REF: 804-06-152
Lot Codes: 183312L03, 200006L01, 224643L01
The hazard
The recall involves broken or missing screws and retaining clips in the orthopedic surgical instrument. This defect may be due to screw tolerance and material strength of the trial used to replicate shell geometry prior to implantation.
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 product mix-up on Feb. 16, 2026, and an RSP Humeral Socket Insert labeling hazard on Jan. 15, 2026. Other recent recalls of similar products include a Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment recall (Feb. 2, 2026) and an Aju Pharm Genesis Dual Thread Screw-In Anchor recall (Dec. 17, 2025).
How to tell if you have this one
Check for the model number REF 804-06-152 on the instrument. The product was sold with lot codes 183312L03, 200006L01, and 224643L01.
Brand
Encore Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Broken Screws
Inspect the instrument for broken or missing screws and retaining clips before use.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
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 terminated this recall 5.3 years 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-1241-2018 (January 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1241-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 28, 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.