FDA Medical Device Recalls (openFDA)
Wright Medical Technology, Inc.: Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
- Recall number
- Z-2105-2023
- Recalling firm
- Wright Medical Technology, Inc.
- Product
- Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
- Status
- Open, Classified
- Initiated
- 2023-06-13
- Posted
- 2023-07-07
- Terminated
- not on file
- Reason
- The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.
- Root cause
- Process control
- Action
- The firm issued a Field Safety Correction Action (FSCA) Medical Devices Vigilance System form to the lead competent authority, ANSM-France, via email on 6/13/2023 for their review and approval for the recall to be carried out in their jurisdiction. The FSCA identified the affected product, a description of the issue, and advice on actions to be taken by the distributor and the user. The advice included to check the inventory to locate the product listed and remove and isolate/quarantine it to prevent accidental use. A business reply form was to be returned by email to confirm receipt of the notification and document product segregation. Upon receipt of the reply form, Stryker will contact the consignee for return of the product. If the devices have been distributed to other organizations, contact details are requested so that Stryker can inform the recipients appropriately. If the consignee is a distributor, they are responsible for notifying their affected customers. An undated recall letter accompanied the FSCA that will be issued once the lead competent authority approves it. The content of the letter was similar to the FSCA and contained a business reply form.
- Quantity
- 106 devices
- Distribution
- There was no U.S. distribution, including government and military. Foreign distribution was made to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
- Lot, serial or model codes
- Lot numbers 2656815 and 2762126, UDI-DI 00889797003926.
- 510(k) numbers
- ["K123954"]
- 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