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Recall Observatory FDA recall evidence

Device 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

Z-2546-2025

July 18, 2025

Class II

Product summary

Firm
Encore Medical, LP
Event
Event 97412
Status
Ongoing
Classification
Class II
Quantity
927 units
Official record key
device-enforcement:Z-2546-2025

Official wording

Reason: Their is a potential that the reamer may kick or bind up during or immediately prior to use.

Code information: Lot Code: Item Number: All Lots GTIN: 00190446843825

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Their is a potential that the reamer may kick or bind up during or immediately prior to use.