China NMPA Product Recall - Inverted shoulder joint system
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On February 7, 2021, Biomet Orthopedics initiated a voluntary Class III recall of its inverted shoulder joint system, identified by Registration No. 20163461824. This action was reported by Zimmer Medical (Shanghai) International Trading Co., Ltd. to the National Medical Products Administration (NMPA). The primary reason for the recall stems from packaging errors affecting specific models and batches of the medical device. While the document does not specify inspection dates, the recall was publicly announced on the aforementioned date. The nature of these packaging errors, though not detailed, necessitated a product recall to ensure patient safety and product integrity. This recall falls under the regulatory oversight of the NMPA, which published the official announcement. The required action by the manufacturer is the voluntary retrieval of affected products from the market. Further detailed information regarding the specific models, specifications, and batches impacted by this recall is available in the "Medical Device Recall Event Report Form," an attachment referenced in the NMPA's announcement. This proactive measure by Biomet Orthopedics, under NMPA guidance, underscores the commitment to addressing product quality concerns promptly.
- Company
- Biomet Orthopedics
ID · cfaa466c-69cc-4d85-ae87-cc046e9a6333