Everest MI XT Outer Dilator, Catalog Number 5101-90168
Check against the official notice below — it lists the full affected range.
Stryker recalled 686 units of the K2M Everest MI XT Outer Dilator (catalog number 5101-90168) due to a manufacturing defect affecting specific lots. The company received two complaints where Inner and Outer Dilators from certain lots failed to fit together properly during surgical procedures. Investigation revealed that some dilators from these lots, as well as other affected lots, contained a manufacturing nonconformance that could prevent proper assembly.
The affected dilators were distributed worldwide, including throughout the United States. The recall involves units from multiple lot numbers: HCBN, HCBP, JUJJ, KFMX, KUPH, KYYV, MDPF, NAKJ, NDGT, and PCCN (GTIN: 10888857261211). The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
Reason for recall: Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance. Distribution: Worldwide distribution - US Nationwide. Quantity: 686 Total Devices Lot/code info: GTIN: 10888857261211; Lot Numbers: HCBN HCBP JUJJ KFMX KUPH KYYV MDPF NAKJ NDGT PCCN
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.