Lower riskMedical device recall · FDA · Published August 22, 2023
Encore Medical: Reverse Shoulder Prosthesis Screws May Be Incorrect Size
Encore Medical recalls reverse shoulder prosthesis screws that may be 3.5mm instead of 5mm, risking surgical delays and poor fixation. Affected units have specific UDI-DI and lot numbers.
Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.
“Encore Medical: Reverse Shoulder Prosthesis Screws May Be Incorrect Size.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57452-encore-medical-reverse-shoulder-prosthesis-screws-may-be-incorrect-size. Based on FDA recall #Z-0098-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0098-2024%22&limit=1).
The FDA announced on 2023-08-22 that Encore Medical, LP is recalling the REVERSE PROSTHESIS SHOULDER SYSTEM due to a packaging error. The hazard involves incorrect screws being included in packages intended for 5mmx30mm screws.
The reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of these incorrect screws could result in surgical delay and inadequate fixation.
Context
GovInfoNow's records show Encore Medical, LP has 43 other recalls on record since 2017-05-31. Other recent recalls include the EMPOWR 3D Knee Ins 11L 14MM VE Product Mix-Up Recall (2026-02-16), the Encore Medical RSP Humeral Socket Insert Recall (2026-01-15), and the Encore Medical EMPOWR Acetabular System Recall (2026-01-05). Other recent recalls of similar products include the Tornier Perip Screw Recall (2025-12-19), the APTUS 2.8 TriLock Screw Recall (2026-01-09), and the XTANT Medical Xpress Pedicle Screw System recall (2026-02-18).
How to tell if you have this one
Check for the UDI-DI number 00888912024570 and lot number 835C2074 on the packaging. The expiration date is March 2029.
Brand
Encore Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Package Details
Look for the UDI-DI number 00888912024570 and lot number 835C2074 on the packaging.
Where it went and when
Where it was distributed
Distributed in 14 states.
Listed by the agency
Not listed
FDA distribution: “US: FL, IN, WI, IA, MN, KY, NY, AZ, RI, WA, OH, SC, VA, TX. OUS: MX” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Florida, Indiana, Iowa, Kentucky, Minnesota, New York, Ohio, Rhode Island, South Carolina, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 57 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-0098-2024 (August 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0098-2024 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.