Device product
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile
Z-2548-2025
Product summary
- Event
- Event 97412
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 447 units
- Official record key
device-enforcement:Z-2548-2025
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: All Lots GTIN: 00190446843818
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
Their is a potential that the reamer may kick or bind up during or immediately prior to use.