FDA Medical Device Recalls (openFDA)
Waldemar Link GmbH & Co. KG (Mfg Site): Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medium, W: 65mm 16-2817/37 Tibial Component Modular, Large, W: 75mm
- Recall number
- Z-2411-2024
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Product
- Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medium, W: 65mm 16-2817/37 Tibial Component Modular, Large, W: 75mm
- Status
- Open, Classified
- Initiated
- 2024-05-22
- Posted
- 2024-07-18
- Terminated
- not on file
- Reason
- Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
- Root cause
- Process design
- Action
- LinkBio issue Urgent Medical Device Correction letter to Distributors via email on June 10, 2024. Letter states reason for recall, health risk and action to take: Please take note of the attached modified Surgical Technique for cementing the Tilastan Proximal Tibial Spacer or Proximal Tibial Segment, provided in Appendix A of this notice. No product return is required. Please respond using the attached Distributor Reply form to indicate your understanding of this Device Correction and of the need to apply the provided cementing surgical technique for the Tilastan Proximal Tibial Spacer or Proximal Tibial Segment, in case the blind screws are unable to be removed. Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions
- Quantity
- 114 units US; 2351 units OUS
- Distribution
- Nationwide Foreign: Algeria Argentina Australia Austria Belarus Belgium Brazil Bulgaria Canada China Colombia Czechia Denmark Ecuador Estonia Finland France Germany Greece Hungary India Indonesia Israel Italy Kenya Lithuania Luxembourg Mexico Netherlands Norway Peru Poland Romania Saudi Arabia Slovakia Slovenia Spain Sweden Switzerland Thailand T¿rkiye Ukraine United Arab Emirates United Kingdom Uruguay Vietnam
- Lot, serial or model codes
- Product UDI-DI 16-2817/02 04026575359202; 16-2817/05 04026575359219; 16-2817/07 04026575359226; 16-2817/32 04026575370870; 16-2817/35 04026575370887; 16-2817/37 04026575370894. All product lots manufactured since 01-Jun-2022.
- 510(k) numbers
- ["K212742","K143179","K151008"]
- PMA numbers
- not on file
- Product code
- JWH
- 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