Z-1652-2026Class II

Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63

Name: Z-1652-2026 Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63
Creator: Waldemar Link GmbH & Co. KG (Mfg Site)
Published: 2026-02-11
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG / initiated 2026-02-11 / Open, Classified

FDA source

Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63 on 2026-02-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1652-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-11
Posted: 2026-03-27
Recalling firm: Waldemar Link GmbH & Co. KG
Product: Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Product code: HTW Bit, Drill
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.
FDA root cause: Under Investigation by firm
Action: On February 11, 2026 "URGENT: MEDICAL DEVICE CORRECTION" letters were emailed to customers. Actions to be taken: Please take note of the correction of the Surgical Technique 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 [email protected] for any questions.
Quantity in commerce: 74 units
Distribution: US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
Product codes and lots: Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1652-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1651-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-26
Z-1652-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-26

Product code HTW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)