# China NMPA Product Recall - 4.5mm fixed drill bit guide spacer

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc-orthopedic-division/c256e4f5-6d9e-4667-9861-5979377fda6b/
Source feed: China

> China NMPA product recall for 4.5mm fixed drill bit guide spacer by Smith & Nephew, Inc. Orthopedic Division published January 22, 2014. Recall level: . On January 6, 2014, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. initi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew, Inc. Orthopaedic Division is recalling orthopedic surgical instruments.
- Company Name: Smith & Nephew, Inc. Orthopedic Division
- Publication Date: 2014-01-22
- Product Name: 4.5mm fixed drill bit guide spacer
- Recall Reason: Due to a manufacturing error, our company's imported 4.5mm fixed drill bit guide spacers were mistakenly fitted with red epoxy resin tape (instead of yellow epoxy resin tape) for the laser-marked 4.5mm fixed drill bit guide spacers. The red epoxy resin tape represents the 3.5mm fixed drill bit guide spacer. If the red epoxy resin tape is not recognized when the procedure is ready, this tape error may cause confusion for the user or a slight delay in the procedure.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew, Inc. Orthopedic Division
- Summary: On January 6, 2014, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. initiated a voluntary recall of orthopedic surgical instruments manufactured by its parent company, Smith & Nephew, Inc. Orthopaedic Division. This action, reported to the National Medical Products Administration (NMPA) on January 15, stemmed from a manufacturing error where a 4.5mm Fixed Drill Bit Guide Spacer (Model: 71173532, Batch No.: 13EM10266) was mistakenly fitted with a red epoxy resin ribbon instead of the correct yellow one. The red ribbon typically signifies a 3.5mm guide spacer, posing a risk of user confusion or minor surgical delays if not identified prior to a procedure. Under the NMPA's regulatory framework, the company's investigation confirmed that only one affected unit was imported into China and remained unsold. Consequently, no impacted products reached the market. The required corrective actions involved isolating the single unit in a warehouse and arranging its return to Smith & Nephew's Orthopedics division in the United States for proper processing. Chinese food and drug administrations were also advised to enhance supervision over similar products.

Company: https://www.globalkeysolutions.net/companies/smith-nephew-inc-orthopedic-division/82243c50-18e1-44ef-893f-7042c1105847/