CLASS II ONGOING Device recall · Reported 24 Jul 2024 · FDA Enforcement Report
Endo Model M Tibial Components Modular Knee Prosthesis System. recalled
Waldemar Link GmbH & Co. KG (Mfg Site) is recalling Endo Model M Tibial Components Modular Knee Prosthesis System., distributed nationwide in the US. The recall was initiated on 22 May 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2410-2024
- FDA event ID
- 94814
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 May 2024
- FDA classified
- 18 Jul 2024
- Reported
- 24 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 22 May 2024 | Recall initiated by company | |
| 18 Jul 2024 | Classified by FDA | +57 days |
| 24 Jul 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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
Where it was distributed
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
Questions about this recall
Why was it recalled?
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
Which lots are affected?
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.
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 94814This product is part of a recall event; the main page for the event is Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | Nationwide |
More recalls from Waldemar Link GmbH & Co. KG (Mfg Site)
All 65| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | Embrace Drill Tower, Standard/Lateral recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | 15 states |
| Device | CLASS II | Embrace Drill Tower, Wedged recalled by Waldemar Link GmbH & Co. KG | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | 15 states |
| Device | CLASS II | Endo-Model Replacement Plateau; Item Number: 15-0027/16 recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | Nationwide |
| Device | CLASS II | Endo-Model Replacement Plateau; Item Number: 15-0027/12 recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | Nationwide |
Other Hip & Knee Implants recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |