Altivate Reamer Recalled Due to Potential Binding Risk
Encore Medical recalls the Altivate Reverse Wedge Glenoid Reamer (Model 804-06-312) because the reamer may kick or bind during surgical use. Approximately 907 units were distributed nationwide across the United States.
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: The recall involves a surgical device with potential for binding or kicking during use, presenting a risk of injury during medical procedures. No patient injuries or illnesses are reported. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported, warranting a High severity score.
Plain-English summary
Encore Medical, LP is recalling the Altivate Reverse Wedge Glenoid Reamer Boss Drill, 6.5mm (Model 804-06-312). This is a surgical reamer tool used in medical procedures. Approximately 907 units were manufactured and distributed with all lot numbers included in this recall (GTIN: 00190446843832).
The reamer has a potential to kick or bind during or immediately prior to surgical use. This malfunction could present a risk of injury during medical procedures.
The product was distributed nationwide across the United States, including: Alabama, Arizona, California, Colorado, Florida, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Nebraska, New Jersey, New York, Ohio, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.
The recalled product
- Product
- 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
- Manufacturer
- Encore Medical, LP
- Hazard
- equipment-malfunction
- surgical-injury-risk
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: All Lots GTIN: 00190446843832
Distribution
Distributed nationwide across the United States.
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