RibLoc U Plus 90 Instrument – Potential Breakage (2023)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Due to potential breakage during use.

Recommended Action

Per FDA guidance

On 11/27/2023, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx and UPS ground to customers informing them that Acumed is initiating a Recall of all field inventory of Part Number RBL2320, Low Profile Primary Guides due to the potential for breakage during use. Customers are instructed to: IMMEDIATELY stop using and/or distributing the product and complete the following actions: 1-The RBL2320, Low Profile Primary Guide is often located with the RBL4030 Instrumentation Tray (as shown in Figure 2 above). Locate the RBL4030 tray and remove the RBL2320, Low Profile Primary guide(s) from the tray. Perform a physical count of their inventory of the RBL2320, Low Profile Primary Guides, and identify any inventory of the batch/lot numbers listed in the table above. 2-Remove the RBL2320, Low Profile Primary Guides removed/segregated in step 1, such that they are taken out of service (i.e., quarantined). 3-Record this data (product, batch/lot number, and quantity) on the Outstanding Field Action Survey found at the end of this recall letter (on page 5). If you do not have product to return, you are still required to complete the survey. 4) Return the completed survey via email to ellie.wood@acumed.net. 5) If you have RBL2320, Low Profile Primary Guide(s) to return, please contact Ellie Wood via email at ellie.wood@acumed.net so that a Return Authorization Number and return instructions can be provided. *Please note, only the RBL2320, Low Profile Primary Guide needs to be returned. 6) If RBL2320, Low Profile Primary Guide product is not returning, please post this Recall Notification Letter on or near the affected products.