Reported Jun 7, 2023 · Ongoing
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for…
Linkbio Corp.
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: Linkbio Corp. · 101 Round Hill Dr Ste 7 · Rockaway, NJ · 07866-1214
Is this the product you have?
- LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement
- Item Number880-325/13
- Lot codes and dates
- UDI-DI04026575258123
- Lot Number1910003
- Amount recalled
- 11 units
Where it was sold
Why it was recalled
Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).
This product could cause temporary or reversible health problems — stop using it.
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