Glenoid reamer heads recalled because they may kick or bind during use
DJO Surgical Altivate Reverse Wedge Glenoid Reamer Heads are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 927 units are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a surgical reamer that kicks or binds during use is a potential harm and no injuries are reported.
Plain-English summary
The DJO Surgical Altivate Reverse Wedge Glenoid Reamer Head, model and catalog number 804-06-311, GTIN 00190446843825, supplied non-sterile in stainless steel and Nitronic, is being recalled across all lots. The recall covers 927 units distributed across more than 15 states.
The recall was issued because there is a potential that the reamer may kick or bind up during or immediately prior to use. The FDA classified the action as Class II.
Hospitals and surgical centres holding this catalog number should quarantine affected stock and follow the manufacturer's instructions for return or replacement.
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
- Affected units
- 927
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
Part of a larger recall action
This product is one of 4 recalled by Encore Medical, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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