Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall LINK Endo Model M and Endo Model SL Tibial Components

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall LINK Endo Model M and Endo Model SL Tibial Componentssee related information
Date Initiated by FirmMay 22, 2024
Date PostedJuly 18, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2410-2024
Recall Event ID 94814
510(K)NumberK143179 K151008 K212742 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductEndo 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
Code Information 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.
Recalling Firm/
Manufacturer		 Waldemar Link GmbH & Co. KG (Mfg Site)
Oststr. 4-10
Norderstedt Germany
For Additional Information ContactSAME
494053995150
Manufacturer Reason
for Recall		Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
FDA Determined
Cause 2		Process design
ActionLinkBio 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 in Commerce552 units; 7351 units OUS
DistributionNationwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JWH
-
-