Z-1511-2026Class II

Waldemar Link GmbH & Co. KG (Mfg Site)

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-03-18

Distribution

Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

Firm state

N/A

Product quantity

44 units (1 US, 43 OUS)

Initiated by

Voluntary: Firm initiated

Reason for recall

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Product description

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;

Code / lot info

Item Number: 16-2840/05; UDI-DI: 04026575359240; Serial/Lot Number: 250513/2083, 250513/2085 , 250513/2086, 250513/2089, 250513/2090, 250513/2092, 250513/2093, 250513/2097 , 250513/2100, 250513/2102, 250513/2104, 250513/2107, 250513/2108, 251013/3245 , 251013/3247, 251013/3250, 251013/3251, 251013/3252, 251013/3253, 251105/0013 , 251105/0016, 251105/0018, 251105/0020, 251105/0032, 251105/0034, 251105/0036 , 251105/0037, 251105/0038, 251105/0039, 250513/2106, 250513/2099, 251105/0014 , 251105/0040, 251105/0002, 250513/2087, 250513/2091, 251013/3246, 251105/0019 , 251013/3249, 251105/0011, 251105/0012, 250513/2103, 250513/2105, 251013/3254;

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →