RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used with a power system to compress the RibLoc plates onto the bone, determine the length of the screw to install, locate the position of the holes to drill, and provide proper orientation for the installation of the screws.
This recall is currently active, issued December 26, 2023. It was issued by Acumed Llc.
- Company
- Acumed Llc
- Recall Initiated
- November 27, 2023
- Posted
- December 26, 2023
- Recall Number
- Z-0618-2024
- Quantity
- 513 units
- Firm Location
- Hillsboro, OR
- Official Source
- View on FDA website ↗
Reason for Recall
Due to potential breakage during use.
Distribution
Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, NJ, OH, OR, SC, TX, UT, VA, WA, and WI. The country of Australia.
Lot / Code Info
Part Number: RBL2320 UDI Code / Batch-Lot Number 10806378118210-538351000000 / 538351 10806378118210-538352000000 / 538352 10806378118210-544036000000 / 544036 10806378118210-554505000000 / 554505 10806378118210-L1810012181031 / L1810012 10806378118210-L1902009190207 / L1902009 10806378118210-L1909017190918 / L1909017 10806378118210-L2001005200130 / L2001005 10806378118210-L2005002200504 / L2005002 10806378118210-L2010046000000 / L2010046 10806378118210-L2010048000000 / L2010048
Root Cause
Unknown/Undetermined by firm
Action Taken
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.