CLASS II ONGOING Device recall · Reported 10 May 2023 · FDA Enforcement Report
Link Sled Knee System Porex Endo Sled Knee Fem Comp, Medium Small recalled
Linkbio is recalling Link Sled Knee System Porex Endo Sled Knee Fem Comp, Medium Small, distributed in Nevada, New York. The recall was initiated on 21 Mar 2023 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-1540-2023
- FDA event ID
- 92088
- Recalling firm
- Linkbio, Rockaway, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Mar 2023
- FDA classified
- 4 May 2023
- Reported
- 10 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 21 Mar 2023 | Recall initiated by company | |
| 4 May 2023 | Classified by FDA | +44 days |
| 10 May 2023 | 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
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
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46
Where it was distributed
NY, NV Foreign: Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus
Stores named: Walmart
Questions about this recall
Is Link Sled Knee System Porex Endo Sled Knee Fem Comp, Medium Small recalled?
Yes. Linkbio recalled Link Sled Knee System Porex Endo Sled Knee Fem Comp, Medium Small on 21 Mar 2023. The recall is Class II and its status is Ongoing. Recall number Z-1540-2023.
Why was it 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
Which lots are affected?
UDI-DI: 04026575429080 All lot numbers within expiration date
Where was it sold?
NY, NV Foreign: Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Linkbio
All 50| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Core Workstation, a component of the Core Shoulder System recalled | Linkbio | Other | Nationwide |
| Device | CLASS II | LINK SymphoKnee System L-Shaped Femoral Augment recalled by Linkbio | Linkbio | Packaging Defects | Nationwide |
| Device | CLASS II | Link Sled Knee System: All Poly Tibial Component recalled by Linkbio | Linkbio | Sterility | NV, NY |
| Device | CLASS II | Link Sled Knee System: All Poly Tibial Component recalled by Linkbio | Linkbio | Sterility | NV, NY |
| Device | CLASS II | Link Sled Knee System: All Poly Tibial Component recalled by Linkbio | Linkbio | Sterility | NV, NY |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |