China NMPA Product Recall - Miniature locking plate system for wrist

This National Medical Products Administration (NMPA) document, dated December 13, 2018, details a voluntary Class II recall initiated by Biomet Trauma, with its agent Zimmer Medical (Shanghai) International Trading Co., Ltd. The recall, reported on November 2, 2018, pertains to specific batches of the Wrist Miniature Locking Bone Plate System (NMPA Registration Certificate No.: 20153461979).

The core issue involves labeling inaccuracies; product packages were found to contain incorrect locking screw sizes. Specifically, a batch (029970) labeled for a 2.7mm x 18mm screw mistakenly contained a 20mm screw, and another batch (029980) labeled for a 2.7mm x 20mm screw included an 18mm screw. Such mislabeled components could pose a risk of surgical complications if used as intended.

Under the NMPA's regulatory framework, the manufacturer opted for a voluntary recall of these affected product batches. The "Medical Device Recall Event Report Form" confirms that none of the identified defective batches were distributed or sold within the Chinese market. Consequently, no direct corrective actions or product retrieval were necessary for China-based distribution. The recall's primary impact is on other regions, such as Japan, where these particular batches may have been supplied, demonstrating a proactive step to mitigate potential patient harm.