Recall Z-0618-2024 ยท LXH Orthopedic Manual Surgical Instrument
Acumed LLC
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.
| Date | Dec 26, 2023 (initiated Nov 27, 2023) |
| Status | Open, Classified |
| Reason | Due to potential breakage during use. |
| Root cause | Unknown/Undetermined by firm |
| Action | 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( |
| Quantity | 513 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.