Synthes (USA) Products LLC: Medical Device Recall in 2018 - (Recall #: Z-0906-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Product Classification:

Class II

Date Initiated: July 26, 2017

Date Posted: March 14, 2018

Recall Number: Z-0906-2018

Event ID: 79157

Reason for Recall:

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Status: Terminated

Product Quantity: 63

Code Information:

Distributed 12-May-2017 to 23-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H270855 5/12/2017 2026-04-30

Distribution Pattern:

Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto Rico, and country of: Canada.

Voluntary or Mandated:

Voluntary: Firm initiated