Synthes Hohmann Retractor Recalled for Incorrect Part Number Etching
Synthes, Inc. is recalling 20 Hohmann retractors because they were mis-etched with the wrong part number.
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 is due to a documentation and labeling error (mis-etched part number) with no reported injuries or functional defects, fitting the criteria for a Low severity recall.
Plain-English summary
Synthes, Inc. is recalling 20 units of the Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm. The product is used to expose bone for procedures.
The recall was initiated because the product and its package were mis-etched with part number 399.24 instead of the correct part number 399.22. The affected lot number is T974302.
The affected units were distributed worldwide and nationwide in the United States, specifically in the states of Tennessee, Maryland, New York, Indiana, New Jersey, Washington, and Virginia, as well as in Canada. Users should stop using the affected devices and contact Synthes, Inc. for instructions on return or replacement.
The recalled product
- Product
- The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures.
- Manufacturer
- Synthes, Inc.
- Hazard
- Affected units
- 20
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)
- part no. 399.24
- lot number T974302
Distribution
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