Materialise Recalls Zimmer Patient Specific Instrument PERSONA CR Pin Guides
Materialise USA LLC is recalling specific Zimmer Patient Specific Instrument PERSONA CR Pin Guides because the packaging contained incorrect components and one guide exceeded size specifications.
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: The recall is classified as FDA Class II, and the source text describes a manufacturing defect (missing component and dimensional deviation) without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Materialise USA LLC is recalling one lot of Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia). These surgical instruments are intended to assist in the positioning of Total Knee Replacement components and guide bone marking during surgery. The recall is limited to a specific lot number and distribution to Minnesota.
The recall was initiated because the device did not meet specifications. The box for a specific case arrived intact but contained two femoral guides instead of the required one femoral guide and one tibial guide. Additionally, one of the femoral guides contained an edge that was 0.04 mm over the specified size.
Healthcare facilities and patients who may have received this specific lot of pin guides should contact Materialise USA LLC for further instructions on how to handle the recalled devices.
The recalled product
- Product
- Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic l
- Manufacturer
- Materialise USA LLC
- Affected units
- 1
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 (1)
- 00-5970-000-25 JTOMA-JL-0636-L8 Pin Guide LOT#: 56602902
Distribution
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