Embrace Drill Tower Surgical Instruments Recalled Due to Mixed-Up Type Descriptions
Waldemar Link recalled Embrace Drill Tower surgical instruments because type descriptions ("standard" vs "wedged") are mixed up in the product overview documentation. Surgeons may select incorrect instrument types due to the confusion.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving mixed-up instrument type descriptions in documentation with no reported illnesses or injuries. The hazard is theoretical—confusion in type designations could lead surgeons to select incorrect instruments—making this a minor labeling/documentation error.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling Embrace Drill Tower surgical instruments (Item Number 645-081/63; UDI/DI: 04026575534722). These instruments are used in shoulder surgical procedures.
The instruments have mixed-up type descriptions in their overview documentation, where "standard" and "wedged" designations are confused. This documentation error could lead surgeons to select the wrong instrument type during procedures.
Six units were distributed nationwide in Alabama and Louisiana. Hospitals, surgical centers, and medical professionals in these states who have received these instruments may be affected.
Healthcare facilities and surgeons should verify the correct instrument type before use. Facilities should contact Waldemar Link for further information regarding this recall.
The recalled product
- Product
- Embrace Drill Tower, Standard/Lateral (25mm)
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- 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: 645-081/63
- UDI/DI: 04026575534722
- 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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