Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used

FDA device recall Z-1493-2014 · posted 2014-04-24 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

Reason for recall

During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. Additional testing identified microscopic aluminum metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches that were introduced during the manufacturing process and were sterilized within the

Action taken

On March 26, 2014, Stryker Instruments sent URGENT MEDICAL DEVICE RECALL NOTIFICATION to their consignees via mail and email. Notification included product description, reason for recall, risk to health, and actions to be taken by the Customer/User. For questions regarding this recall please contact Stryker Instruments: Monday-Friday 8am-5pm (EST) Angela Ragainis/Kelly Jo Whipple 269-389-4354 / 269-389-2921 angela.ragainis@stryker.com / kellyjo.whipple@stryker.com Customers will be asked to sign the Business Reply Form stating they have read the Notification and followed all instructions within. Customers will return affected product to Stericycle for destruction using a return label provided by Stryker or Stericycle. Upon receipt of affected product a credit will be issued to customer account. In addition, facilities are being asked to research their records for patient issues that may have been associated with the use of a recalled device, such as infection and/or inflammation.

Root cause

Material/Component Contamination

Status

Terminated

Product code

FYD

Quantity affected

35,310 unexpired units

Distribution

Worldwide Distribution-USA (nationwide) including DC and the 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, N

Date initiated

2014-03-26

Date posted

2014-04-24

Date terminated

2014-12-11

Location

Portage, MI