Surgical Reamer Head Recalled Due to Potential Mechanical Failure
Encore Medical is recalling 927 units of the ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD due to a potential for mechanical failure during surgical use, where the reamer may kick or bind. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II surgical device with a reported potential for mechanical failure during patient procedures. Per the rubric, risk-of-harm products without reported injuries score High (3). No actual injuries or illnesses have been reported in the source.
Plain-English summary
Encore Medical is recalling 927 units of the ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD, a surgical instrument used in orthopedic shoulder procedures. The device is made of stainless steel/Nitronic material and was manufactured as non-sterile inventory.
The recall was issued because there is a potential that the reamer may kick or bind up during or immediately prior to use. This mechanical failure could occur during surgical procedures.
The recalled units were distributed nationwide to hospitals and surgical centers in 25 states and Puerto Rico, including Alabama, Arizona, California, Colorado, and Florida. The affected products have Model/Catalog Number 804-06-311 and GTIN 00190446843825.
Healthcare facilities should check their inventory for affected units. While no injuries or illnesses have been reported, any affected instruments should be addressed appropriately with the manufacturer.
The recalled product
- 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
- Manufacturer
- Encore Medical, LP
- Hazard
- mechanical-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: Item Number: All Lots GTIN: 00190446843825
Distribution
Distributed nationwide across the United States.
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