Recall Z-2107-2023 ยท GWO Plate, Cranioplasty, Preformed, Alterable
Osteomed, LLC
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
| Date | Jul 7, 2023 (initiated May 31, 2023) |
| Status | Open, Classified |
| Reason | Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. |
| Root cause | Nonconforming Material/Component |
| Action | On June 6, 2023, OsteoMed/Acumed issued an "Urgent: Medical Device Recall" notification to affected consignees via FedEx Ground. OsteoMed/Acumed asked consignees to take the following actions: IMMEDIATELY stop using and/or distributing the product and complete the following actions: 1) Perform a physical count of your inventory. Identify any inventory of the lot number listed above that is still in its packaging. Locate and remove the affected, unopened, unused packages of screws, such that they are out of service (i.e., quarantined). 2) Record this data (product and quantity) on the surve |
| Distribution | Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, KS, KY, MD, MO, MT, NE, NY, TN, TX and the country of SG. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111176 | OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM Osteomed LP, Aug 15, 2011 |