# China NMPA Product Recall - Inverted shoulder joint system

Source: https://www.globalkeysolutions.net/records/china_product_recall/biomet-orthopedics/36e6f582-a324-481c-8679-ce3aaaf84689/
Source feed: China

> China NMPA product recall for Inverted shoulder joint system by Biomet Orthopedics published January 24, 2019. Recall level: Level 2. The National Medical Products Administration (NMPA) announced a Class II voluntary recall of the Bio

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Biomet Orthopedics initiates recall of inverted shoulder joint system
- Company Name: Biomet Orthopedics
- Publication Date: 2019-01-24
- Product Name: Inverted shoulder joint system
- Recall Level: Level 2
- Recall Reason: Zimmer Biomet is recalling certain inverted shoulder joint miniature scapulae with tapered adapters because the product packaging may be missing the tapered adapter. The product packaging should contain one (1) scapulae and one (1) tapered adapter, but products within this recall scope may be packaged with two (2) scapulae but without the (0) adapter, or with two (2) adapters but without the (0) scapulae.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Biomet Orthopedics
- Summary: The National Medical Products Administration (NMPA) announced a Class II voluntary recall of the Biomet Orthopedics Inverted Shoulder Joint System (Registration No.: 20163461824). This regulatory communication, published on January 24, 2019, follows a report submitted by Zimmer Medical (Shanghai) International Trading Co., Ltd. on December 27, 2018. The recall stems from a critical manufacturing and packaging issue: specific product units were found to be missing a crucial tapered adapter. The correct packaging should include one shoulder lug and one tapered adapter; however, affected units were incorrectly packed with either two shoulder lugs and no adapter, or two adapters and no shoulder lug. This medical device is intended for severe shoulder joint disease, rotator cuff defects, or failed shoulder replacements, requiring suitable patient anatomy and deltoid function. While the recall affects specific product models (010000589) and batches (994110, 921950) distributed in the USA, Australia, and Japan, it is important to note that these particular affected batches were not sold within the Chinese market. Consequently, the NMPA document explicitly states that no corrective actions or handling methods are required for products in China. This exemplifies the NMPA's framework for overseeing medical device safety and ensuring transparent communication regarding global product quality issues.

Company: https://www.globalkeysolutions.net/companies/biomet-orthopedics/9bcf230e-90e5-4f4e-8673-6456e0ed8783/