RecallRadar

FDA Device recall Z-1511-2026

Endo-Model SL Connection Component incl

On 2026-03-18 the FDA classified a Class II recall of Endo-Model SL Connection Component incl by Waldemar Link And Kg Mfg Site, citing the potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1511-2026
ClassificationClass II
Statusongoing
Initiated2026-01-12
Published2026-03-18
Last updated2026-09-13 11:58 UTC
CompanyWaldemar Link And Kg Mfg Site
DistributionUS

Product

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

Reason

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

Identifiers

code_info
Item Number: 16-2840/05; UDI-DI: 04026575359240; Serial/Lot Number: 250513/2083, 250513/2085 , 250513/2086, 250513/2089…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;

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1511-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.