Surgical Specialties Mexico S DE RL DE CV: Medical Device Recall in 2016 - (Recall #: Z-0068-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.

Product Classification:

Class II

Date Initiated: September 24, 2016

Date Posted: October 19, 2016

Recall Number: Z-0068-2017

Event ID: 75273

Reason for Recall:

Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.

Status: Terminated

Product Quantity: 512 boxes (2560 units)

Code Information:

MAWX380, MAZD460, MAZR350, MBCF540

Distribution Pattern:

US: OH, PA, CO, MA, DE, CA, NY, VA, WA, NJ, CT, FL, TX, NH, ID, OK, AZ, GA, PA, NV, VT. Worldwide: Spain, Italy, United Kingdom, Portugal, Turkey, Germany, Denmark,

Voluntary or Mandated:

Voluntary: Firm initiated