[Recalled] LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028 — Product manufactured using UHMWPE raw material over 5 years of age has the pote… | FDA 2023-12-01

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Howmedica Osteonics Corp.

• Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip, knee, shoulder, elbow or — Class II
• Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910 — Class II
• PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031 — Class II
• radial stem implant #3 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. — Class II
• PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411 — Class II
• SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110 — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.