The Recall Desk
HighFDA (Devices)·Z-1257-2024·Announced 2024-03-13

Embrace Drill Tower Shoulder Instruments Recalled for Mislabeled Type Descriptions

Waldemar Link is recalling Embrace Drill Tower surgical instruments due to mixed-up type descriptions ("standard" vs "wedged") in the accompanying surgical technique documentation.

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 instrument recall where mislabeled type descriptions could lead to incorrect instrument selection, presenting a risk of harm despite no reported injuries to date.

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling the Embrace Drill Tower, Wedged (25mm) shoulder surgical instruments due to mixed-up type descriptions in the accompanying surgical technique documentation.

The surgical technique overview for the Embrace Shoulder Instruments Drill Tower contains incorrect type descriptions, with instruments mislabeled as either "standard" or "wedged" when the types are not clearly distinguished. This involves Article reference numbers 645-081/62 and 645-081/63.

Six units have been distributed nationwide to healthcare facilities in Alabama and Louisiana. The recall affects all lots of the LINK Embrace Drill Tower surgical instruments (Item Number 645-081/62; UDI/DI: 04026575534715).

The recalled product

Product
Embrace Drill Tower, Wedged (25mm)
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Category
Medical Device — Surgical Instruments
Hazard
  • mis-labeling

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 (3)

  • Item Number: 645-081/62
  • UDI/DI: 04026575534715
  • All lots of the LINK Embrace Drill Tower surgical instruments.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category