Reported Jan 23, 2019 · Terminated
LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference…
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?
- LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference
- Number 172-916/12 Product UsageThe LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is
- indicated for the following conditionsRevision arthroplasty due to juxta-articular bone defects Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone Revision of loosened femoral prosthesis components with periprosthetic/subprosthetic fracture Deformed proximal femur due to fractures or osteotomies Correction of bone deficiencies, e.g. due to tumors Large post-revision and post-trauma segmental bone defects Oncological and revision surgery from tibial to hip area (in conjunction with Endo-Model¿ SL Rotational and Hinge Knee Prostheses) The device is intended for cemented and cementless use
- Lot codes and dates
- Lot numbers
1435077151502917181031435077150401/021717341681726056171810317341681515029
- Lot numbers
- Amount recalled
- 11
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The reaming guide and the guide rod can't be screwed into the intended depth. The reason for this is a reduced depth of the core hole in the stem. A reaming guide that is not screwed in completely may lead to a proximal preparation in the depth that is not sufficient and to a neck that can't be positioned correctly. The correct fit of the neck can't be verified by means of the guide rod.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Waldemar Link GmbH & Co. KG (Mfg Site) recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.