Z-2547-2025 Class II Ongoing
FDA device recall Z-2547-2025 was initiated by Encore Medical, LP on July 18, 2025 and is designated Class II. Reason for recall: Their is a potential that the reamer may kick or bind up during or immediately prior to use. The recall status is ongoing. Affected quantity: 907 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 17, 2025
- Initiation Date
- July 18, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 907 units
Product Description
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non Sterile
Reason for Recall
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
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.
Code Information
Lot Code: All Lots GTIN: 00190446843832