FDA Medical Device Recalls (openFDA)
Waldemar Link GmbH & Co. KG (Mfg Site): Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12, 15-2837/11, 15-2837/12, 15-2838/11, 15-2838/12, 15-3815/11, 15-3815/12, 15-3816/11, 15-3816/12, 15-3817/11, 15-3817/12, 15-3818/11, 15-3818/12, 15-8521/05, 15-8521/07, 15-8521/09, 15-8521/11, 15-8521/15, 15-8521/25, 15-8521/27, 15-8521/29, 15-8521/31, 15-8521/33
- Recall number
- Z-2410-2024
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Product
- Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12, 15-2837/11, 15-2837/12, 15-2838/11, 15-2838/12, 15-3815/11, 15-3815/12, 15-3816/11, 15-3816/12, 15-3817/11, 15-3817/12, 15-3818/11, 15-3818/12, 15-8521/05, 15-8521/07, 15-8521/09, 15-8521/11, 15-8521/15, 15-8521/25, 15-8521/27, 15-8521/29, 15-8521/31, 15-8521/33
- 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
- 552 units; 7351 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: 1 15-2814/01 04026575316243 2 15-2814/02 04026575316281 3 15-2814/03 04026575316298 4 15-2814/04 04026575316304 5 15-2815/11 04026575316007 6 15-2815/12 04026575316014 7 15-2816/11 04026575316021 8 15-2816/12 04026575316038 9 15-2817/11 04026575316052 10 15-2817/12 04026575316069 11 15-2818/11 04026575316076 12 15-2818/12 04026575316083 13 15-2834/01 04026575316731 14 15-2834/02 04026575316748 15 15-2834/03 04026575316755 16 15-2834/04 04026575316762 17 15-2835/11 04026575316557 18 15-2835/12 04026575316564 19 15-2836/11 04026575316571 20 15-2836/12 04026575316588 21 15-2837/11 04026575316595 22 15-2837/12 04026575316601 23 15-2838/11 04026575316618 24 15-2838/12 04026575316625 25 15-3815/11 04026575034727 26 15-3815/12 04026575034734 27 15-3816/11 04026575034741 28 15-3816/12 04026575034758 29 15-3817/11 04026575164042 30 15-3817/12 04026575164059 31 15-3818/11 04026575164028 32 15-3818/12 04026575164035 33 15-8521/05 04026575383207 34 15-8521/07 04026575383221 35 15-8521/09 04026575383238 36 15-8521/11 04026575383245 37 15-8521/13 04026575383269 38 15-8521/15 04026575383283 39 15-8521/25 04026575386406 40 15-8521/27 04026575386413 41 15-8521/29 04026575386420 42 15-8521/31 04026575386437 43 15-8521/33 04026575386444 44 15-8521/35 04026575386451 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