Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Waldemar Link GmbH & Co. KG (Mfg Site) · The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a pr…
Open FDA's page for this record- Cfres ID
- 221502
- Product res number
- Z-2934-2026
- Event date initiated
- 2026-07-06
- Event date posted
- 2026-08-11
- Recall status
- Open, Classified
- Res event number
- 99405
- Product code
- KRO
- Product description
- Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
- Code info
- UDI-DI 04026575432134 Lot for Implant REF 15-0027/16: 2604069
- Firm FEI number
- 3003386935
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Address 1
- Ost Str. 4-10 4-10 ost str.
- City
- Norderstedt
- Country
- Germany
- Additional info contact
- Terry Sheridan Powell 494053995150
- Root cause description
- Process change control
- Product quantity
- 1 US; 9 OUS
- Distribution pattern
- Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.
- Reason for recall
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.
- Action
Foreign manufacturer, Waldemar Link GmbH & Co KG, notified importer LinkBio Corp. on 7/6/2026 via email. LinkBio then notified the single US consignee by email/Docusign on 7/7/2026. Customer was instructed to return the affected product to LinkBio.
- K numbers
- K143179
- Harmonized identifiers (openFDA)
- Device name
- Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3510
- Device class
- 2
- K number
- K092138, K150028, K163311, K242871, K013385, K040749, K133152, K151008, K223528, K062301, K070978, K021260, K003504, K994207, K060131, K223069, K823115, K021489, K140898, K013031, K261898, K110940, K982160, K020381, K140509, K140900, K011810, K052685, K051570, K233980, K031480, K152431, K001548, K002552, K021714, K091453, K051479, K101815, K013035, K131393 +47 more
- Registration number
- 3007189546, 2249615, 1835251, 3013176080, 3000264985, 3010097171, 1834331, 3010220595, 3014252644, 3005751028, 3007539489, 3010057495, 3005061536, 3010386387, 3015516266, 3004635447, 3004748528, 9616680, 1833920, 3008110533, 3003639920, 1450662, 3009760038, 1833986, 3004153896, 2133928, 3016438694, 3002808022, 1825034, 3003387384, 9610726, 3013450937, 1000517406, 9681465, 1828464, 3015207155, 9610612, 1424263, 3035366890, 2183946 +97 more
- FEI number
- 3007189546, 1000118610, 3002806315, 3013176080, 3000264985, 3010097171, 3010220595, 3014252644, 3002807172, 1000116116, 3005751028, 3007539489, 3010057495, 3005061536, 3010386387, 3015516266, 3004635447, 3004748528, 1000132037, 3002459190, 3002807113, 3008110533, 3003639920, 1450662, 3009760038, 1000221916, 3004153896, 1000306303, 3002287318, 3016438694, 3002808022, 1825034, 3003387384, 3013450937, 1000517406, 1000115656, 1828464, 3015207155, 3002807231, 3001451451 +97 more