[pending] Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Pending LLM rewrite. Source: FDA_DEVICE Z-1652-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
The recalled product
- Product
- Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Category
- Medical Device — Devices
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
Distributed in 15 states:
- AL
- AZ
- FL
- GA
- IL
- IN
- KS
- KY
- LA
- MI
- NC
- OH
- OK
- TX
- VA
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