Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0380-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.

Product Classification:

Class II

Date Initiated: July 31, 2013

Date Posted: December 4, 2013

Recall Number: Z-0380-2014

Event ID: 66411

Reason for Recall:

Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw.

Status: Terminated

Product Quantity: 98

Code Information:

Lot 3420620

Distribution Pattern:

Nationwide Distribution including PA, CA, FL, MO, KS, IN, IL, WV, KY, LA, NM, SC, IA, TX, AZ, GA, NC, OK, NY, TN, MI, CO, and MT.

Voluntary or Mandated:

Voluntary: Firm initiated