Z-2071-2017 Class II Terminated
FDA device recall Z-2071-2017 was initiated by Stryker Instruments Div. of Stryker Corporation on March 10, 2017 and is designated Class II. Reason for recall: Product shipped proximate to or past the expiration date listed on the product label. The recall status is terminated (terminated July 21, 2017). Affected quantity: 65.
Recall Details
- Product Type
- Devices
- Report Date
- May 17, 2017
- Initiation Date
- March 10, 2017
- Termination Date
- July 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65
Product Description
Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system is comprised of PROFESS Registration Stickers, a PROFESS Patient Tracker, and a PROFESS Adaptor Cable.
Reason for Recall
Product shipped proximate to or past the expiration date listed on the product label.
Distribution Pattern
US (nationwide) Distribution to the states of : CA, CT, GA, IL, IN, MA, MD, NC, OH, PA, TN, and TX.
Code Information
Lot #202085 Stryker Product Number: 6001-420-000