FDA Medical Device Recalls (openFDA)
Waldemar Link GmbH & Co. KG (Mfg Site): MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
- Recall number
- Z-2641-2023
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Product
- MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
- Status
- Open, Classified
- Initiated
- 2023-07-14
- Posted
- 2023-09-26
- Terminated
- not on file
- Reason
- Product is labeled with incorrect offset.
- Root cause
- Under Investigation by firm
- Action
- On July 17, 2023, firm notified consignees via email. Customers were advised to return the affected product to LinkBio. Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions.
- Quantity
- 8 units
- Distribution
- Domestic distribution to AL, NJ, NV.
- Lot, serial or model codes
- UDI-DI: 04026575182329 Item Number: 183-610/05 Lots: 210526/0781; 210526/0777; 210526/0779; 210526/0771; 210526/0772; 210526/0783; 210526/0784; 210526/0778
- 510(k) numbers
- ["K200607"]
- PMA numbers
- not on file
- Product code
- LPH
- Firm FEI
- 3003386935
- Firm city
- Norderstedt
- Firm state
- not on file
- Firm country
- Germany
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