36MM COCR MODULAR HD -6MM
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling 23 units of its 36MM COCR Modular HD component from lot 236840 due to a manufacturing error. One piece from a different lot was mixed into lot 236840 and is incorrectly etched with a -6MM offset instead of the correct +3MM offset marking. This incorrect etching and the associated size difference affect how the product functions.
The affected lot has been removed from the field. The recall is limited to distribution outside the United States. The source does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field.
Reason for recall: One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field. Distribution: Outside USA Quantity: 23 Lot/code info: 11-363660 UDI Number: (01) 00880304210509 (17) 270507 (10) 236840 Product Number: 11-363660 Lot Number: 236840
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.