PlainRecalls
FDA Devices Moderate Class II Terminated

SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.

Reported: November 18, 2015 Initiated: October 14, 2015 #Z-0235-2016

Product Description

SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.

Reason for Recall

It was reported that packaging was not properly sealed.

Details

Units Affected
1202
Distribution
US ( nationwide) Distribution to the states of : MN, OH, CA, IN, WI, FL, GA, MO, IA, MT, LA, KS, TX, TN, WY, MD, NJ, WA, PA, SC, NY, MI, AT, HI, MN, AR, AZ, IL, IA, KY, MS, UT, NC, VA, CO, ME and ID., Internationally to Canada.
Location
Tempe, AZ

Frequently Asked Questions

What product was recalled?
SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.. Recalled by Stryker Sustainability Solutions. Units affected: 1202.
Why was this product recalled?
It was reported that packaging was not properly sealed.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 18, 2015. Severity: Moderate. Recall number: Z-0235-2016.