Reported May 10, 2023 · Ongoing
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14
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 SLED Knee SystemALL POLY
- TIBIAL COMPONENT 9X58MM Item Number15-2028/14
- Lot codes and dates
- UDI-DI04026575359462 All lot numbers within the labeled expiration date
- Amount recalled
- 15 units
This recall covers 48 products
The agency filed one notice per product. You are reading one of them; the other 47 are below.
35 more are in the archive.
Where it was sold
Why it was recalled
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
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 Linkbio Corp. 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.