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FDA · FDA event 98342 · Posted Mar 10, 2026
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.
| Model | Description | Lot / serial range | Manufactured | Status |
|---|---|---|---|---|
| Z-1511-2026 | Z-1511-2026 | 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; | Not provided in the normalized record | Ongoing |
| Z-1520-2026 | Z-1520-2026 | Item Number: 15-8521/15; UDI-DI: 04026575383283; Serial/Lot Number: 250805/0020, 250805/0021, 250805/0023, 250805/0024; | Not provided in the normalized record | Ongoing |
| Z-1513-2026 | Z-1513-2026 | Item Number: 16-2840/02; UDI-DI: 04026575359233; Serial/Lot Number: 250925/0640 , 250925/0641, 250925/0642, 250925/0646, 250925/0650, 250925/0652, 250925/0653 , 250925/0656, 250925/0658, 250925/0669, 250925/0670, 250925/0680, 250925/0681 , 250925/0682, 250925/0687, 250925/0689, 250925/0690, 250925/0691, 250925/0693 , 250925/0694, 251110/3293, 250925/0660, 250925/0661, 250925/0684, 250925/0685 , 250925/0657, 250925/0663, 250925/0659, 250925/0678, 251110/3288, 251110/3292 , 251110/3303, 251110/3313, 250925/0683, 250925/0674, 250925/0644, 250925/0665 , 250925/0668, 250925/0671, 250925/0673, 250925/0676, 250925/0664 , 250925/0651 , 251110/3297, 251110/3289, 250925/0639, 250925/0648, 250925/0688, 250925/0696; | Not provided in the normalized record | Ongoing |
| Z-1516-2026 | Z-1516-2026 | Item Number: 15-2836/11; UDI-DI: 04026575316571; Serial/Lot Number: 250623/3643, 250623/3644, 250623/3645, 250623/3646, 250623/3648, 250812/2812, 250812/2811; | Not provided in the normalized record | Ongoing |
| Z-1517-2026 | Z-1517-2026 | Item Number: 15-8030/12; UDI-DI: 04026575048151; Serial/Lot Number: 250721/0194, 250721/0212, 250721/0211, 250721/0209; | Not provided in the normalized record | Ongoing |
| Z-1523-2026 | Z-1523-2026 | Item Number: 15-0027/16; UDI-DI: 04026575432134; Serial/Lot Number: 2550412, 2550413, 2549228; | Not provided in the normalized record | Ongoing |
| Z-1518-2026 | Z-1518-2026 | Item Number: 15-8521/09; UDI-DI: 04026575383238; Serial/Lot Number: 250728/0038, 250728/0039, 250728/0040, 250728/0041, 250728/0042, 250728/0043, 250728/0044, 250728/0045; | Not provided in the normalized record | Ongoing |
| Z-1514-2026 | Z-1514-2026 | Item Number: 16-2840/07; UDI-DI: 04026575359257; Serial/Lot Number: 250925/0480 , 250925/0481, 250925/0482, 250925/0483, 250925/0484, 250925/0486, 250925/0489 , 250925/0491, 250925/0492, 250925/0494, 250925/0503, 250925/0504, 250925/0345 , 250925/0346, 250925/0349, 250925/0350, 250925/0351, 250925/0352, 250925/0356 , 250925/0369, 250925/0501, 250925/0365, 250925/0368, 250925/0490, 250925/0488 , 250925/0479, 250925/0495, 250925/0500, 250925/0496, 250925/0499, 250925/0367; | Not provided in the normalized record | Ongoing |
| Z-1522-2026 | Z-1522-2026 | Item Number: 15-0027/12; UDI-DI: 04026575431960; Serial/Lot Number: 2549036; | Not provided in the normalized record | Ongoing |
| Z-1515-2026 | Z-1515-2026 | Item Number: 15-2835/12; UDI-DI: 04026575316564; Serial/Lot Number: 241210/1809; | Not provided in the normalized record | Ongoing |
| Z-1519-2026 | Z-1519-2026 | Item Number: 15-8521/11; UDI-DI: 04026575383245; Serial/Lot Number: 250728/2220, 250728/2222, 250728/2223, 250728/2224, 250728/2225, 250728/2226, 250728/2227; | Not provided in the normalized record | Ongoing |
| Z-1512-2026 | Z-1512-2026 | Item Number: 15-0027/15; UDI-DI: 04026575432127; Serial/Lot Number: 2549190; | Not provided in the normalized record | Ongoing |
| Z-1521-2026 | Z-1521-2026 | Item Number: 15-0027/11; UDI-DI: 04026575431953; Serial/Lot Number: 2549126, 2549127; | Not provided in the normalized record | Ongoing |
Jan 12, 2026
Recall initiated
Date recorded by the FDA.
Mar 10, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.