Stryker Hoffman LRF Wire Tensioner Adjustment Ring May Become Loose
Stryker is recalling 39 Hoffman LRF Wire Tensioner devices because the adjustment ring may loosen, preventing proper tension setting. No injuries reported.
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: This is an FDA Class II recall of a medical device with a risk of malfunction (loose adjustment ring preventing proper tension setting), but no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Stryker GmbH is recalling 39 Stryker Hoffman LRF Wire Tensioner devices (Model REF 4933-9-100, Lot #J43995, UDI-DI 07613252611035). These devices are components of the Hoffmann LRF System.
The adjustment ring on these devices may become loose, which could prevent the wire tension from being set correctly. No illnesses or injuries have been reported in association with this issue.
The affected devices were distributed worldwide, including the United States (Arizona, California, Colorado, Florida, Georgia, Kentucky, Massachusetts, Michigan, Nebraska, New Jersey, Ohio, Oregon, and Texas) and internationally (Germany, Japan, the Netherlands, and the United Kingdom).
For further information and instructions regarding this recall, affected parties should contact Stryker.
The recalled product
- Product
- Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
- Manufacturer
- Stryker GmbH
- Affected units
- 39
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)
- Lot #J43995
- UDI-DI 07613252611035.
Distribution
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