Agency classClass IIOur severity:High FDA (Devices)·Z-2549-2025·Announced 2025-09-17

Shoulder glenoid tray kits recalled because the reamer may kick or bind

DJO Surgical FA S Altivate Reverse Glenoid Tray kits are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 439 kits are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 FA S Altivate Reverse Glenoid Tray is being recalled across all lots. Enovis shoulder devices are intended for the treatment of patients who are candidates for shoulder arthroplasty. The recall covers 439 kits 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 these kits should quarantine them and follow the manufacturer's instructions for return or replacement.

The recalled product

Product: Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for…
Manufacturer: Encore Medical, LP
Category: Medical Device — Orthopedic Instrument
Hazard: instrument-malfunction
surgical-reamer
class-ii
Affected units: 439

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 GTIN:

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

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.

See all 4 products in this recall →

Same manufacturer · Encore Medical, LP

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