FDA Devices Moderate Class II Terminated

Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Reported: March 14, 2018 Initiated: July 26, 2017 #Z-0907-2018

Product Description

Reason for Recall

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

Details

Recalling Firm: Synthes (USA) Products LLC
Units Affected: 6
Distribution: 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.
Location: West Chester, PA

Frequently Asked Questions

What product was recalled? ▼

Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.. Recalled by Synthes (USA) Products LLC. Units affected: 6.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 14, 2018. Severity: Moderate. Recall number: Z-0907-2018.