Stryker Instruments Div. of Stryker Corporation: Medical Device Recall in 2016 - (Recall #: Z-2204-2016)

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:

5.0mm Round Fluted Bur, Super Long

Product Classification:

Class II

Date Initiated: June 16, 2016
Date Posted: July 20, 2016
Recall Number: Z-2204-2016
Event ID: 74562
Reason for Recall:

Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating surgical intervention.

Status: Terminated
Product Quantity: 25
Code Information:

5190-010-050  5.0mm Round Fluted Bur, Super Long , Lot Number: 15322017

Distribution Pattern:

US Distribution to the states of : CA, IL, SD Foreign: Canada, Netherlands

Voluntary or Mandated:

Voluntary: Firm initiated