Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX"… — Class III medical device recall Z-0891-2026
Ongoing recall by Orthofix U.S. LLC, reported 2025-12-17, distributed nationwide. Labeling contains claims that are not consistently present.
| Recall number | Z-0891-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthofix U.S. LLC, Lewisville, TX, United States |
| Recall initiated | 2025-11-03 |
| Classified | 2025-12-11 |
| Reported by FDA | 2025-12-17 |
| Distributed | Nationwide (US) |
| Quantity | 61,977 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 18257200030415, 18257200030439, 18257200030453, 18257200030477, 18257200030491, 18257200030514, 18257200030538, 18257200030552, 18257200030576, 18257200030590, 18257200030613, 18257200030637, 18257200030651, 18257200030675, 18257200030699, 18257200030712, 18257200030736, 18257200030750, 18257200030774, 18257200030798, 18257200030811, 18257200030835, 18257200030859, 18257200030873, 18257200030897 and 47 more |
| Model numbers | 12MML, 12MMW, 37-3106SP, 6MMH |
Product
Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 12mm L, 7mm H, Parallel; 37-3108SP 12mm W X 12mm L, 8mm H, Parallel; 37-3109SP 12mm W X 12mm L, 9mm H, Parallel; 37-3110SP 12mm W X 12mm L, 10mm H, Parallel; 37-3111SP 12mm W X 12mm L, 11mm H, Parallel; 37-3112SP 12mm W X 12mm L, 12mm H, Parallel; 37-3113SP 12mm W X 12mm LW, 13mm H, Parallel; 37-3114SP 12mm W X 12mm WL, 14mm H, Parallel; 37-3006SP 12mm W X 12mm L, 6mm H, 5¿ Lordotic; 37-3007SP 12mm W X 12mm L, 7mm H, 5¿ Lordotic; 37-3008SP 12mm W X 12mm L, 8mm H, 5¿ Lordotic; 37-3009SP 12mm WL X 12mm L, 9mm H, 5¿ Lordotic; 37-3010SP 12mm W X 12mm L, 10mm H, 5¿ Lordotic; 37-3011SP 12mm W X 12mm L, 11mm H, 5¿ Lordotic; 37-3012SP 12mm W X 12mm L, 12mm H, 5¿ Lordotic; 37-3013SP 12mm W X 12mm L, 13mm H, 5¿ Lordotic; 37-3014SP 12mm W X 12mm L, 14mm H, 5¿ Lordotic; 37-3207SP 12mm W X 12mm L, 7mm H, 10¿ Lordotic; 37-3208SP 12mm W X 12mm L, 8mm H, 10¿ Lordotic; 37-3209SP 12mm W X 12mm L, 9mm H, 10¿ Lordotic; 37-3210SP 12mm W X 12mm L, 10mm H, 10¿ Lordotic; 37-3211SP 12mm W X 12mm L, 11mm H, 10¿ Lordotic; 37-3212SP 12mm W X 12mm L, 12mm H, 10¿ Lordotic; 37-4106SP 15mm W X 12mm L, 6mm H, Parallel; 37-4107SP 15mm W X 12mm L, 7mm H, Parallel; 37-4108SP 15mm W X 12mm L, 8mm H, Parallel; 37-4109SP 15mm W X 12mm L, 9mm H, Parallel; 37-4110SP 15mm W X 12mm L, 10mm H, Parallel; 37-4111SP 15mm W X 12mm L, 11mm H, Parallel; 37-4112SP 15mm W X 12mm L, 12mm H, Parallel; 37-4113SP 15mm W X 12mm L, 13mm H, Parallel; 37-4114SP 15mm W X 12mm L, 14mm H, Parallel; 37-4006SP 15mm W X 12mm L, 6mm H, 5¿ Lordotic; 37-4007SP 15mm W X 12mm L, 7mm H, 5¿ Lordotic; 37-4008SP 15mm W X 12mm L, 8mm H, 5¿ Lordotic; 37-4009SP 15mm W X 12mm L, 9mm H, 5¿ Lordotic; 37-4010SP 15mm W X 12mm L, 10mm H, 5¿ Lordotic; 37-4011SP 15mm W X 12mm L, 11mm H, 5¿ Lordotic; 37-4012SP 15mm W X 12mm L, 12mm H, 5¿ Lordotic; 37-4013SP 15mm W X 12mm L, 13mm H, 5¿ Lordotic; 37-4014SP 15mm W X 12mm L, 14mm H, 5¿ Lordotic; 37-4207SP 15mm W X 12mm L, 7mm H, 10¿ Lordotic; 37-4208SP 15mm W X 12mm L, 8mm H, 10¿ Lordotic; 37-4209SP 15mm W X 12mm L, 9mm H, 10¿ Lordotic; 37-4210SP 15mm W X 12mm L, 10mm H, 10¿ Lordotic; 37-4211SP 15mm W X 12mm L, 11mm H, 10¿ Lordotic; 37-4212SP 15mm W X 12mm L, 12mm H, 10¿ Lordotic; 37-5106SP 15mm W X 15mm L, 6mm H, Parallel; 37-5107SP 15mm W X 15mm L, 7mm H, Parallel 37-5108SP 15mm W X 15mm L, 8mm H, Parallel; 37-5109SP 15mm W X 15mm L, 9mm H, Parallel; 37-5110SP 15mm W X 15mm L, 10mm H, Parallel; 37-5111SP 15mm W X 15mm L, 11mm H, Parallel; 37-5112SP 15mm W X 15mm L, 12mm H, Parallel; 37-5113SP 15mm W X 15mm L, 13mm H, Parallel; 37-5114SP 15mm W X 15mm L, 14mm H, Parallel; 37-5006SP 15mm W X 15mm L, 6mm H, 5¿ Lordotic; 37-5007SP 15mm W X 15mm L, 7mm H, 5¿ Lordotic; 37-5008SP 15mm W X 15mm L, 8mm H, 5¿ Lordotic; 37-5009SP 15mm W X 15mm L, 9mm H, 5¿ Lordotic; 37-5010SP 15mm W X 15mm L, 10mm H, 5¿ Lordotic; 37-5011SP 15mm W X 15mm L, 11mm H, 5¿ Lordotic; 37-5012SP 15mm W X 15mm L, 12mm H, 5¿ Lordotic; 37-5013SP 15mm W X 15mm L, 13mm H, 5¿ Lordotic; 37-5014SP 15mm W X 15mm L, 14mm H, 5¿ Lordotic; 37-5207SP 15mm W X 15mm L, 7mm H, 10¿ Lordotic; 37-5208SP 15mm W X 15mm L, 8mm H, 10¿ Lordotic; 37-5209SP 15mm W X 15mm LW, 9mm H, 10¿ Lordotic; 37-5210SP 15mm W X 15mm L, 10mm H, 10¿ Lordotic; 37-5211SP 15mm W X 15mm L, 11mm H, 10¿ Lordotic; 37-5212SP 15mm W X 15mm L, 12mm H, 10¿ Lordotic;
Reason for recall
Labeling contains claims that are not consistently present.
Machine access
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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.