Z-2546-2025Class II

Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number...

Name: Z-2546-2025 Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number...
Creator: Encore Medical, LP
Published: 2025-07-18
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2025-07-18 / Open, Classified / root cause: design

FDA source

Encore Medical, LP began a recall of Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic... on 2025-07-18. FDA classified it as Class II and gives the reason as "Their is a potential that the reamer may kick or bind up during or immediately prior to use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2546-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-18
Posted: 2025-09-10
Recalling firm: Encore Medical, LP
Product: Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-Sterile
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Root cause tag: design
FDA root cause: Device Design
Action: On July 29, 2025, Enovis issued a "Urgent Medical Device Recall Notification via Email to affected consignees. On August 4, 2025, Enovis issued an update to the recall notification via E-Mail requesting consignees rework affected trays and returned affected products. Enovis asked consignees to take the following actions: 1. Continue using the wedge reamer assembly while carefully inspecting and following the specific details in the supplied Quality Bulletin. 2. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 3. Please see the attached quality Bulletin 4. By 9/13/25, the firm will reach out regarding reworking and returning trays. 5. Acknowledge receipt of notification.
Quantity in commerce: 927 units
Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IA, IL, IN, KS, KY, LA, MD, ME, NE, NJ, NY, OH, PR, RI, SC, TN, TX, UT, VA, WA, WI.
Product codes and lots: Lot Code: Item Number: All Lots GTIN: 00190446843825

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2546-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2546-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-10
Z-2547-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-10
Z-2548-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-10
Z-2549-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-10

Product code KWS

K233481Class IIAltiVate Reverse® GlenoidEncore Medical L.P. / cleared 2024-05-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)