Recall Z-2171-2021 ยท HSB Rod, Fixation, Intramedullary And Accessories
Stryker GmbH
Nail Insertion Sleeve, elastic T2 Tibia SPI 8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
| Date | May 27, 2021 |
| Status | Open, Classified |
| Reason | The devices have a different inner diameter than the diameter specified on the outer box label. |
| Root cause | Process control |
| Action | An URGENT MEDICAL DEVICE RECALL notice dated 5/27/21 was sent to customers. Actions to be Taken by the Customer/User: Our records indicate that you may have received one or more of the affected products. It is Strykers responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important communication. We therefore request that you read this notice carefully and complete the following actions. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be aware within your |
| Quantity | 242 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131365 | T2 TIBIAL NAILING SYSTEM Stryker Trauma AG, Oct 10, 2013 |