Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
Recall
- Recall Number
- Z-1291-2022
- Event Number
- 90216
- Firm
- Wright Medical Technology, Inc.
- FEI Number
- 3010667733
- Product Code
- HSN
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- June 2, 2022
- Address
- 1023 Cherry Rd, Memphis, TN, 38117-5423
Description
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
The instrument is incorrectly color coded.
The recalling firm issued letters dated 2-June-2022 via email. The letter was issued to the distributors but the noticed was flagged to the attention of health care professionals, operators of medical devices, and distributors. The letter provided the product description, issue, potential risks, and actions needed as follows: (1) Immediately check the inventory to locate the product listed on the attached business reply form and remove it from its point of use; (2) Return the enclosed business reply form by email to confirm receipt of this notification and document product segregation; (3) Upon receipt of the completed business reply form, Stryker will contact the consignee to arrange for the return and replacement of the product; (4) Maintain awareness of this communication internally until all required actions have been completed within the consignee facility; (5) If the product has been further distributed, notify all affected parties at once about the recall. A copy of this notification can be used to send to the consignees. If possible, the recalling firm should be informed if any of the devices have been further distributed, including contact details, so that the recalling firm can inform the recipients appropriately. If the consignee first receiving the letter is a distributor, they are responsible for notifying their affected customers.
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IA, IL, MA, MI, MN, MO, NC, NY, OH, PA, TX, and WA. The countries of Australia, Belgium, Canada, France, Germany, Hong Kong, Israel, Sweden, Switzerland, and United Kingdom.
35 units