Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling the Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter (item 010000589) because packages may contain incorrect components. Each package should contain one baseplate and one taper adapter, but some packages may instead contain two baseplates with no adapter, or two adapters with no baseplate. This recall affects 3 units that were distributed nationwide, including in Colorado, Minnesota, Ohio, and Wyoming. The affected lot numbers are 488150 and 564110.
The source document does not specify what consumers or healthcare providers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters
Reason for recall: Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters Distribution: US Nationwide distribution including in the states of CO, MN, OH, WY. Quantity: 3 units Lot/code info: Lot Numbers: 488150 -UDI (01) 00880304532465 (17) 300623 (10) 488150; and 564110- UDI (01) 00880304532465 (17) 300609 (10) 564110
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.