REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
FDA Recall Z-0626-2024 · Posted 2024-01-02
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Recalling FirmEncore Medical, LP
Recall StatusCompleted
Product CodePHX
Date Initiated2023-10-05
Product Quantity2 units
Reason for Recall
Mislabeling
Firm Action
On October 5, 2022, DJO Global (Enovis company) issued a "Urgent Medical Device Recall" Notification via E-Mail. DJO asked consignees to take the following actions:
1. This notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred.
2. Review your stock for the affected products and lot numbers for the items to be returned.
3. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. You will be provided with a shipping label to return the affected product.
4. Return all affected devices (quantities listed above) using the RMA number.
Report any adverse events related to this issue to Customer Service. Additionally, adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Root Cause
Packaging process control
Distribution Pattern
US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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