Embrace shoulder drill tower surgical technique lists mixed-up article numbers
Waldemar Link is recalling the Embrace Drill Tower because the surgical technique document has mixed-up article numbers in the instrument overview, although the individual surgical steps are correct.
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: Rubric level 2 covers minor labelling errors: article numbers are transposed in an instrument overview while the source confirms the surgical steps themselves are correct.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling the Embrace Drill Tower, Wedged (25mm), item number 645-081/62. About 75 units were distributed across 15 US states. The FDA has classified this recall as Class II.
The surgical technique for the Embrace Shoulder Instruments Drill Tower has mixed-up article numbers in the overview of the instruments. The individual surgical steps described in the surgical technique are correct.
All lots are affected. The device carries UDI 04026575534715.
Facilities can identify affected instruments by the item number and UDI above, and may contact Waldemar Link GmbH & Co. KG for further information.
The recalled product
- Product
- Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Affected units
- 75
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: Item Number: 645-081/62
- UDI: 04026575534715
- Lot Number: All Lots
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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