FDA Medical Device Recalls (openFDA)
Signature Orthopedics Pty Limited: Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
- Recall number
- Z-1694-2021
- Recalling firm
- Signature Orthopedics Pty Limited
- Product
- Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
- Status
- Terminated
- Initiated
- 2021-04-20
- Posted
- not on file
- Terminated
- 2023-01-19
- Reason
- Product mislabeled, with the incorrect product inside the package.
- Root cause
- Labeling mix-ups
- Action
- On 04/20/21 the firm sent a letter to its consignee with the following instructions: examine your inventory and quarantine product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once by forwarding this letter. Please complete the Customer Acknowledgement Form.
- Quantity
- 3 units
- Distribution
- US Nationwide distribution in the state of NC.
- Lot, serial or model codes
- LOT# 71541-1
- 510(k) numbers
- ["K121297"]
- PMA numbers
- not on file
- Product code
- MEH
- Firm FEI
- 3008262872
- Firm city
- West
- Firm state
- Lane Cove
- Firm country
- Australia
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