FDA Medical Device Recalls (openFDA)
Wright Medical Technology, Inc.: Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
- Recall number
- Z-1291-2022
- Recalling firm
- Wright Medical Technology, Inc.
- Product
- Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
- Status
- Open, Classified
- Initiated
- 2022-06-02
- Posted
- not on file
- Terminated
- not on file
- Reason
- The instrument is incorrectly color coded.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 35 units
- Distribution
- 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.
- Lot, serial or model codes
- Lot #2039558, GTIN 00889797006552.
- 510(k) numbers
- ["K140749"]
- PMA numbers
- not on file
- Product code
- HSN
- Firm FEI
- 3010667733
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28