The Recall Desk
ModerateFDA (Devices)·Z-1258-2024·Announced 2024-03-13

Embrace Drill Tower Surgical Instruments Recalled Due to Mixed-Up Type Descriptions

Waldemar Link recalled Embrace Drill Tower surgical instruments because type descriptions ("standard" vs "wedged") are mixed up in the product overview documentation. Surgeons may select incorrect instrument types due to the confusion.

What this means for you

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: This is a Class II recall involving mixed-up instrument type descriptions in documentation with no reported illnesses or injuries. The hazard is theoretical—confusion in type designations could lead surgeons to select incorrect instruments—making this a minor labeling/documentation error.

Plain-English summary

Waldemar Link GmbH & Co. KG is recalling Embrace Drill Tower surgical instruments (Item Number 645-081/63; UDI/DI: 04026575534722). These instruments are used in shoulder surgical procedures.

The instruments have mixed-up type descriptions in their overview documentation, where "standard" and "wedged" designations are confused. This documentation error could lead surgeons to select the wrong instrument type during procedures.

Six units were distributed nationwide in Alabama and Louisiana. Hospitals, surgical centers, and medical professionals in these states who have received these instruments may be affected.

Healthcare facilities and surgeons should verify the correct instrument type before use. Facilities should contact Waldemar Link for further information regarding this recall.

The recalled product

Product
Embrace Drill Tower, Standard/Lateral (25mm)
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Category
Medical Device — Surgical Instruments
Hazard
Affected units
6

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: 645-081/63
  • UDI/DI: 04026575534722
  • All lots of the LINK Embrace Drill Tower surgical instruments.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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.

See all 2 products in this recall →

Related recalls

Same manufacturer · Waldemar Link GmbH & Co. KG (Mfg Site)

See all →