SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-43
Summary
The FDA issued a Class II for SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-40 by Howmedica Osteonics Corp.. Reason: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the p.
Details
Source
Device Recall
External ID
Z-3205-2026
Action Date
2026-09-23
Status
Ongoing
Category
device
Product Description
SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322 SYSTEM ONE BIPOLAR 44MM 6074-4422 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Lot/Code Info: 78-5-0910 UDI-DI 07613327366006 Lot 30582401 6074-4022 UDI-DI 07613327031775 Lots 2M5NTY LH25R5 M36N83 6074-4322 UDI-DI 07613327031805 Lot W40E3T 6074-4422 UDI-DI 07613327031812 Lot R84K20
Quantity Affected: 12,156 US
Reason for Recall
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-30
Company
Mahwah, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Howmedica Osteonics Corp. has 124 FDA actions in our database, including 124 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Howmedica Osteonics Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Howmedica Osteonics Corp. have FDA actions?
Howmedica Osteonics Corp. has 124 FDA actions in our database, including 124 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3205-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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