# China NMPA Product Recall - Anterior cruciate ligament reconstruction surgical instruments

Source: https://www.globalkeysolutions.net/records/china_product_recall/b-braun-medical-shanghai-international-trading-co-ltd/0df257a4-5f07-467f-b8f1-74ebb7fcc812/
Source feed: China

> China NMPA product recall for Anterior cruciate ligament reconstruction surgical instruments by B. Braun Medical (Shanghai) International Trading Co., Ltd. published May 08, 2017. Recall level: Level II. The National Medical Products Administration (NMPA) announced a voluntary Class II recall by B. Brau

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: B. Braun Medical (Shanghai) International Trading Co., Ltd. voluntarily recalls surgical instruments for anterior cruciate ligament reconstruction.
- Company Name: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Publication Date: 2017-05-08
- Product Name: Anterior cruciate ligament reconstruction surgical instruments
- Recall Level: Level II
- Recall Reason: In the perforating femoral drill bit of model FO087R with a diameter of 8.0mm, product with batch number 52194770 was mistakenly engraved as 6.0mm instead of 8.0mm during the laser engraving process in the production process.
- Discovering Company: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) announced a voluntary Class II recall by B. Braun Medical (Shanghai) International Trading Co., Ltd., published on May 8, 2017. The recall pertains to Anterior Cruciate Ligament Reconstruction Surgical Instruments, specifically a perforated femoral drill bit, model FO087R, with a diameter of 8.0mm and batch number 52194770. The main issue identified by the company was an manufacturing error where the laser marking on the product indicated 6.0mm instead of the correct 8.0mm. This mislabeling could lead to the incorrect drill bit size being used during surgery, potentially impacting patient safety and surgical efficacy. Under the NMPA's regulatory framework, B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated this recall as a required action to address the quality deviation. A Class II recall signifies that the product might cause temporary or reversible adverse health consequences, or the likelihood of serious adverse health consequences is remote. Further details, including specific models and batch numbers, are provided in the associated "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/b-braun-medical-shanghai-international-trading-co-ltd/58112c52-92f6-4aa8-acd6-c5efd892653b/