Plastic trial heads carry inconsistent size terminology and color coding
Plastic Trial Head Brown with 7 mm neck length is being recalled because of inconsistent size terminology and colour coding used on the labeling. 17 units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for inconsistent labeling terminology and colour coding, with no device defect or clinical consequence stated in the source.
Plain-English summary
The Plastic Trial Head Brown, 7 mm neck length, item number 175-928/15, UDI-DI 04026575150700, is being recalled. The action covers 17 units, serial numbers C126168 and C424053.
The stated reason is inconsistent size terminology and colour coding used on the labeling. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Distribution was worldwide, including nationwide in the United States across Arizona, California, Florida, Indiana, Kansas and Louisiana among other states. The trial heads are supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the item number, UDI-DI and serial numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Item Number: 175-928/15. UDI-DI: 04026575150700. Serial Numbers: C126168
- C424053
Distribution
Part of a larger recall action
This product is one of 2 recalled by Waldemar Link GmbH & Co. KG (Mfg Site) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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