Recall Z-1461-2023 ยท JXI Cuff, Nerve
Baxter Healthcare Corporation
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
| Date | Apr 25, 2023 (initiated Mar 27, 2023) |
| Status | Open, Classified |
| Reason | The product is brittle and potentially crumbling upon handling or when being removed from its package. |
| Root cause | Under Investigation by firm |
| Action | Baxter issued an Urgent Medical Device Recall notice to its consignees on 03/27/2023 by mail (USPS). The notice explained the issue and the risk and requested the following actions: 1. Immediately locate, isolate, and cease all use of the affected lot number of the product. 2. Contact Synovis MCA to arrange for return and replacement of the product. Synovis MCA can be reached at 800-510-3318 or 205-941-0111 between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday. Please have your Synovis MCA account number, product code, lot number, and quantity of product to be retur |
| Quantity | 169 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of China, Germany, Sweden, Norway, Netherlands, Greece, Switzerland, France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983007 | NEUROTUBE Neuroregen, LLC, Mar 22, 1999 |