FDA recall Z-0891-2026

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

Reason for recall

Labeling contains claims that are not consistently present.

Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.

Key facts

Status

Ongoing

Initiation date

2025-11-03

Report date

2025-12-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lewisville, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0891-2026