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.
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: 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)
- Hazard
- Affected units
- 6
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
Part of a larger recall action
This product is one of 2 recalled by Waldemar Link GmbH & Co. KG (Mfg Site) 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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