Reported Jul 24, 2024 · Ongoing
Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03,…
Waldemar Link GmbH & Co. KG (Mfg Site)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Waldemar Link GmbH & Co. KG (Mfg Site) · Oststr. 4-10 · Norderstedt · N/A
Is this the product you have?
- 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
- Lot codes and dates
44 of 44 products
Products covered by this recall Model / number Barcodes Product as published 15-2814/01040265753162432 15-2814/02040265753162813 15-2814/03040265753162984 15-2814/04040265753163045 15-2815/11040265753160076 15-2815/12040265753160147 15-2816/11040265753160218 15-2816/12040265753160389 15-2817/110402657531605210 15-2817/120402657531606911 15-2818/110402657531607612 15-2818/120402657531608313 15-2834/010402657531673114 15-2834/020402657531674815 15-2834/030402657531675516 15-2834/040402657531676217 15-2835/110402657531655718 15-2835/120402657531656419 15-2836/110402657531657120 15-2836/120402657531658821 - Amount recalled
- 552 units; 7351 units OUS
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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