Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
Check against the official notice below — it lists the full affected range.
Howmedica Osteonics Corp. recalled boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025), a device intended to be implanted to replace a hip joint. The problem is that some boxes labeled as containing the 6-Petal version actually contained the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015) instead. A total of 40 units from Lot Number G6091225 with an expiration date of June 2022 were affected.
The recalled product was distributed to Australia, France, Finland, Germany, Italy, Japan, New Zealand, the Netherlands, Norway, Romania, Spain, Sweden, and the United Kingdom. The source record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)
Reason for recall: Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015) Distribution: Foreign: Australia, France, Finland, Germany, Italy, Japan, New Zealand, Netherlands, Norway, Romania, Spain, Sweden and UK Quantity: 40 units Lot/code info: Lot Number: G6091225, Exp. Date: 2022-06 UDIs: (01)04546540167712(17)220618(10)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.