# China NMPA Product Recall - Bone plate screw system - straight locking plate

Source: https://www.globalkeysolutions.net/records/china_product_recall/zimmer-inc/52439547-93ee-47c0-bdc3-1114d07ef851/
Source feed: China

> China NMPA product recall for Bone plate screw system - straight locking plate by Zimmer Inc. published January 13, 2016. Recall level: . Zimmer Inc. initiated a global voluntary recall for specific batches of its Straight Locking Plate a

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zimmer Inc. recalls its buttress plate screw system - straight locking plate.
- Company Name: Zimmer Inc.
- Publication Date: 2016-01-13
- Product Name: Bone plate screw system - straight locking plate
- Recall Reason: The product label on the affected batch of non-sterile steel plate packaging does not match the product inside the packaging. Product number: 00-4936-011-13 (straight reconstruction locking steel plate, 11 holes, 144mm) batch number: 62968956, while the product inside the packaging is product number: 00-4936-008-07 (3.5mm pressure locking steel plate, 8 holes, 105mm) batch number: 62968974.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Zimmer Inc.
- Summary: Zimmer Inc. initiated a global voluntary recall for specific batches of its Straight Locking Plate and Screw System, as reported by Zimmer (Shanghai) Medical International Trading Co., Ltd. to the National Medical Products Administration (NMPA) on December 14, 2015. The core issue involved significant product labeling discrepancies where the packaging for certain 11-hole Straight Reconstruction Locking Steel Plates (Product No. 00-4936-011-13, Batch No. 62968956) incorrectly contained 8-hole 3.5mm Pressure Locking Steel Plates (Product No. 00-4936-008-07, Batch No. 62968974). While the affected products were distributed internationally between February and June 2015, the company confirmed that these recalled batches were not sold or imported into China. Consequently, no related complaints or patient injuries have been reported within China. Under the NMPA's regulatory oversight, the administration mandated that all provincial, autonomous region, and municipal food and drug administrations enhance their management and scrutiny of similar medical devices to uphold product safety and accurate identification.

Company: https://www.globalkeysolutions.net/companies/zimmer-inc/05cec43c-1d05-4504-b41e-c83d04872937/