Waldemar Link GmbH & Co. KG (Mfg Site): Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Product
- Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
- Recall initiated
- 2026-02-11
- Code info
- Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;
- Product quantity
- 74 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Norderstedt
- Country
- Germany
- Event id
- 98431
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