FDA DevicesClass II
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Published: April 1, 2026Recall ID: Z-1652-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Affected Products
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Additional Source Details
| Field | Value |
|---|---|
| City | Norderstedt |
| Event id | 98431 |
| Address 1 | Ost Str. 4-10 |
| Code info | Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots; |
| Postal code | N/A |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 74 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260211 |
| Initial firm notification | |
| Center classification date | 20260326 |
Overview
- Recalling FirmWaldemar Link GmbH & Co. KG (Mfg Site)
- StatusOngoing
- Risk LevelClass II
- DistributionUS distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA