Generic Name: Spinal Internal Fixation Device — Brand Name: Reline Spinal System(*)
Recall Summary New Basic Japan Co., Ltd. is recalling RELINE Spinal System titanium rods (5.5X35mm, lot CLC1030XC) used in spine surgery because the lot number printed on the regulatory label does not match the lot number on the product itself. The manufacturer has confirmed the products themselves are not defective and no health injuries have been reported. This recall affects a specific shipment of 12 units distributed on May 12, 2025.
- Recalling firm
- Name of Manufacturer/Distributor: New Basic Japan Co., Ltd. — Address of Manufacturer/Distributor: Nittochi Ginza Building, 7-14-13 Ginza, Chuo-ku, Tokyo — License Type: Class I Medical Device...
- Product
- Lot: 販売名：RELINE スパイナルシステム (*) 製品番号：11355035 ロット番号：CLC1030XC 製品名：RELINE Ti ロッド 5.5X35mm MAS ロードティック 出荷数量：12 出荷時期：令和7年5月12日. Use: 本品は、胸椎から仙骨における、外傷、変性疾患、腫瘍及び脊柱変形等の脊椎疾患のため、脊椎の後方固定術に 使用することを目的とした脊椎内固定器具であり、一般的な固定、支持またはアライメント補正を目的に使用す る。. Health hazards: 本不具合は法定ラベルのロット番号の記載不備であり、製品自体に問題はありません。したがって、健康被害の 発生はないと考えます。なお、当該事象が原因で健康被害が発生したとの情報は入手していません。
- Reason
- We have discovered products at our domestic manufacturing facility where the lot number on the regulatory label (CLC1030XC) differs from the lot number printed directly on the product (CL1030X C). Following an investigation, we determined that all products in this lot were affixed with regulatory labels bearing the incorrect lot number, and we have therefore decided to recall them.
- Classification
- Class III
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/cba97d43-f2c8-4f1a-aee7-964fd4469e2d