510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0904-2024Class II

P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107

Howmedica Osteonics Corp / initiated 2023-12-01 / Open, Classified / root cause: manufacturing process
FDA source (opens on fda.gov)

Howmedica Osteonics Corp. began a recall of P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107 on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0904-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Howmedica Osteonics Corp
Product
P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107
Product code
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Reason for recall
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.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
Stryker issued Urgent Medical Device Recall Letter (Product Field Action #: 3306872)through third party Sedgwick via UPS on 12/1/23. Letter states reason for recall, health risk and action to take: Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the affected product in Part/Lot Number Attachment: PFA 3306872 starting on page 3. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to [email protected] 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return ALL affected product to: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3306872; Please include Tracking information on the package. If you have any questions or concerns after reviewing this letter, please contact Customer Service at (201) 831-5000. For questions pertaining to the recall, email [email protected]
Distribution
Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
Product codes and lots
GTIN: 07613153076155 Lot Numbers: 61311701, 62122001

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0904-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0869-2024Class IIOngoingVoluntary: Firm initiated
Z-0870-2024Class IIOngoingVoluntary: Firm initiated
Z-0871-2024Class IIOngoingVoluntary: Firm initiated
Z-0872-2024Class IIOngoingVoluntary: Firm initiated
Z-0873-2024Class IIOngoingVoluntary: Firm initiated
Z-0874-2024Class IIOngoingVoluntary: Firm initiated
Z-0875-2024Class IIOngoingVoluntary: Firm initiated
Z-0876-2024Class IIOngoingVoluntary: Firm initiated
Z-0877-2024Class IIOngoingVoluntary: Firm initiated
Z-0878-2024Class IIOngoingVoluntary: Firm initiated
Z-0879-2024Class IIOngoingVoluntary: Firm initiated
Z-0880-2024Class IIOngoingVoluntary: Firm initiated
Z-0881-2024Class IIOngoingVoluntary: Firm initiated
Z-0882-2024Class IIOngoingVoluntary: Firm initiated
Z-0883-2024Class IIOngoingVoluntary: Firm initiated
Z-0884-2024Class IIOngoingVoluntary: Firm initiated
Z-0885-2024Class IIOngoingVoluntary: Firm initiated
Z-0886-2024Class IIOngoingVoluntary: Firm initiated
Z-0887-2024Class IIOngoingVoluntary: Firm initiated
Z-0888-2024Class IIOngoingVoluntary: Firm initiated
Z-0889-2024Class IIOngoingVoluntary: Firm initiated
Z-0890-2024Class IIOngoingVoluntary: Firm initiated
Z-0891-2024Class IIOngoingVoluntary: Firm initiated
Z-0892-2024Class IIOngoingVoluntary: Firm initiated
Z-0893-2024Class IIOngoingVoluntary: Firm initiated
Z-0894-2024Class IIOngoingVoluntary: Firm initiated
Z-0895-2024Class IIOngoingVoluntary: Firm initiated
Z-0896-2024Class IIOngoingVoluntary: Firm initiated
Z-0897-2024Class IIOngoingVoluntary: Firm initiated
Z-0898-2024Class IIOngoingVoluntary: Firm initiated
Z-0899-2024Class IIOngoingVoluntary: Firm initiated
Z-0900-2024Class IIOngoingVoluntary: Firm initiated
Z-0901-2024Class IIOngoingVoluntary: Firm initiated
Z-0902-2024Class IIOngoingVoluntary: Firm initiated
Z-0903-2024Class IIOngoingVoluntary: Firm initiated
Z-0904-2024Class IIOngoingVoluntary: Firm initiated
Z-0905-2024Class IIOngoingVoluntary: Firm initiated
Z-0906-2024Class IIOngoingVoluntary: Firm initiated
Z-0907-2024Class IIOngoingVoluntary: Firm initiated
Z-0908-2024Class IIOngoingVoluntary: Firm initiated
Z-0909-2024Class IIOngoingVoluntary: Firm initiated
Z-0910-2024Class IIOngoingVoluntary: Firm initiated
Z-0911-2024Class IIOngoingVoluntary: Firm initiated
Z-0912-2024Class IIOngoingVoluntary: Firm initiated
Z-0913-2024Class IIOngoingVoluntary: Firm initiated
Z-0914-2024Class IIOngoingVoluntary: Firm initiated
Z-0915-2024Class IIOngoingVoluntary: Firm initiated
Z-0916-2024Class IIOngoingVoluntary: Firm initiated
Z-0917-2024Class IIOngoingVoluntary: Firm initiated
Z-0918-2024Class IIOngoingVoluntary: Firm initiated
Z-0919-2024Class IIOngoingVoluntary: Firm initiated
Z-0920-2024Class IIOngoingVoluntary: Firm initiated
Z-0921-2024Class IIOngoingVoluntary: Firm initiated
Z-0922-2024Class IIOngoingVoluntary: Firm initiated
Z-0923-2024Class IIOngoingVoluntary: Firm initiated
Z-0924-2024Class IIOngoingVoluntary: Firm initiated
Z-0925-2024Class IIOngoingVoluntary: Firm initiated
Z-0926-2024Class IIOngoingVoluntary: Firm initiated