Data Foundry

Medical device recalls 2026

Endo-Model SL Connection Component incl — Class II medical device recall Z-1514-2026

Ongoing recall by Waldemar Link GmbH & Co. KG (Mfg Site), reported 2026-03-18, distributed nationwide. The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a

Recall numberZ-1514-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmWaldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, N/A, Germany
Recall initiated2026-01-12
Classified2026-03-10
Reported by FDA2026-03-18
DistributedNationwide (US)
Countries outside the USCA, CH, CO, DE, ES, GB, HU, IN, IT, NL, RO, SA
Quantity31 units
Reason classesdevice malfunction
UPC / GTIN / UDI-DI04026575359257
Lot numbers250925/0345, 250925/0346, 250925/0349, 250925/0350, 250925/0351, 250925/0352, 250925/0356, 250925/0365, 250925/0367, 250925/0368, 250925/0369, 250925/0479, 250925/0480, 250925/0481, 250925/0482, 250925/0483, 250925/0484, 250925/0486, 250925/0488, 250925/0489, 250925/0490, 250925/0491, 250925/0492, 250925/0494, 250925/0495, 250925/0496, 250925/0499, 250925/0500, 250925/0501, 250925/0503, 250925/0504
Model numbers16-2840/07

Product

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1514-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.