CLASS II ONGOING Device recall · Reported 1 Apr 2026 · FDA Enforcement Report
Embrace Drill Tower, Wedged recalled by Waldemar Link GmbH & Co. KG
Waldemar Link GmbH & Co. KG (Mfg Site) is recalling Embrace Drill Tower, Wedged, distributed in 15 states. The recall was initiated on 11 Feb 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1651-2026
- FDA event ID
- 98431
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Feb 2026
- FDA classified
- 26 Mar 2026
- Reported
- 1 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 11 Feb 2026 | Recall initiated by company | |
| 26 Mar 2026 | Classified by FDA | +43 days |
| 1 Apr 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Where it was distributed
US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
AlabamaArizonaFloridaGeorgiaIllinoisIndianaKansasKentuckyLouisianaMichiganNorth CarolinaOhioOklahomaTexasVirginia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;
Where was it sold?
US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98431| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Embrace Drill Tower, Standard/Lateral recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | 15 states |
More recalls from Waldemar Link GmbH & Co. KG (Mfg Site)
All 65| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | Embrace Drill Tower, Standard/Lateral recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | 15 states |
| Device | CLASS II | Endo-Model Replacement Plateau; Item Number: 15-0027/16 recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | Nationwide |
| Device | CLASS II | Endo-Model Replacement Plateau; Item Number: 15-0027/12 recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | Nationwide |
| Device | CLASS II | Endo-Model Replacement Plateau; Item Number: 15-8521/11 recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | Nationwide |
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| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |