Surgical Reamer Sleeve Recalled Due to Potential Binding During Use
Encore Medical is recalling 447 units of the ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE because the surgical reamer may bind or kick during use.
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 FDA Class II medical device poses a risk of harm through mechanical failure during surgical use, but no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products without reported injury are classified as High (3).
Plain-English summary
Encore Medical, LP is recalling 447 units of the DJO SURGICAL ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE (Model 804-06-310, Non-Sterile). The reamer may bind or kick during or immediately prior to surgical use.
The product was distributed nationwide across multiple 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. All lot numbers are affected by this recall.
The recalled product
- 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
- Manufacturer
- Encore Medical, LP
- Hazard
- equipment-malfunction
- 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: 00190446843818
Distribution
Distributed nationwide across the United States.
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