Embrace Drill Tower, Wedged (25mm)

FDA device recall Z-1257-2024 · posted 2024-03-06 · Open, Classified

Recall details

Recalling firm

Waldemar Link GmbH & Co. KG (Mfg Site)

Reason for recall

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

Action taken

LinkBio Corp issued Urgent: Medical Device Correction letter via email on 2/8/24 to Distributors. Letter states reason for recall, health risk and action to take: Please take note of the correction of the Surgical Techniques noted in section 2. No product return is required. Please respond using the attached Distributor Reply form to indicate your understanding of this Device Correction and of the need to follow the updated surgical technique. Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

HTW

Quantity affected

6 units

Distribution

US Nationwide distribution in the states of AL and LA.

Date initiated

2024-01-29

Date posted

2024-03-06

Location

Norderstedt, Germany