Match Point System surgical instrument recalled due to incorrect procedure side labeling
The Match Point System surgical instrument was recalled because the procedure side on planning reports was incorrectly marked as 'Left' instead of 'Right' for right-side procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall involves a labeling error where the procedure side was incorrectly marked as Left instead of Right. Per the severity rubric, documentation issues without reported injuries or illnesses correspond to a Low severity score.
Plain-English summary
The Match Point System, a surgical instrument used for intraoperative positioning of glenoid components during shoulder arthroplasty, was recalled by the FDA. The recall was issued because the procedure side indicated in the top header of Shoulder Case Planning Reports incorrectly showed "Left" for surgical plans intended for a "right" procedure side.
Consumers who received instruments with this labeling error should not proceed with the procedure until corrected documentation is provided. The manufacturer, Materialise N.V., is responsible for correcting the labeling issue across all affected units.
No injuries or illnesses have been reported related to this recall. The issue represents a documentation error rather than a safety concern, warranting a low-severity classification.
The recalled product
- Product
- Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are…
- Manufacturer
- Materialise N.V.
- Hazard
- Affected units
- 128
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 (8)
- ID #s: 804-03-057
- 804-25-148
- 804-03-058
- 804
- 07
- 022 UDI #s: E314804030570
- E314804251480
- E314804070220
Distribution
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