LINK SymphoKnee Patella Sizing Template recalled due to incorrect markings
LINK BIO CORP is recalling the LINK SymphoKnee Patella Sizing Template (Item Number 881-509/00, Lot C225066) because markings on two arms of the instrument were mixed up during manufacturing.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The product has incorrect markings that could affect its proper use, but no adverse events have been documented. Per the rubric, risk-of-harm products without reported injury are scored at most 3 (High).
Plain-English summary
LINK BIO CORP is recalling the LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00 (Lot C225066). Eight units of this surgical instrument were distributed nationwide in Florida, Georgia, Kansas, Ohio, and Wisconsin.
The template contains incorrect markings on two arms of the instrument due to a manufacturing error. During the laser marking process, the triangular template was inserted upside down, causing the markings to be mixed up.
The FDA classified this as a Class II recall. Healthcare facilities that received this product should contact LINK BIO CORP for instructions on the affected units.
The recalled product
- Product
- LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
- Manufacturer
- LINK BIO CORP
- Affected units
- 8
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 (3)
- Item Number: 881-509/00
- UDI-DI: 04026575310203
- Lot number: C225066.
Distribution
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