Stryker Recalls Hoffman LRF Telescopic Struts Due to Breakage
Stryker Howmedica Osteonics Corp. is recalling 165 Hoffman LRF Telescopic Struts because three complaints reported the devices breaking during load-bearing use in patients weighing over 250 lbs.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (breakage) in a load-bearing medical device, which aligns with the rubric criteria for 'Severe' severity involving significant injury or structural defects.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 165 units of Hoffman LRF Telescopic Struts. These medical devices are used for bone fixation in fracture and reconstructive surgery. The recall covers specific catalog numbers and lot codes for Extra Short, Short, Medium, and Long strut lengths.
The recall was initiated after three complaints were filed reporting that the telescopic struts broke during load-bearing application. These incidents occurred in patients with a body weight greater than 250 lbs. The devices are distributed nationwide.
Healthcare providers and patients should stop using the affected devices and contact Stryker Howmedica Osteonics Corp. for instructions on replacement or return. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of…
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 165
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 (19)
- Z04197
- Z09163
- Z09597
- Z12135
- Z04199
- Z09161
- Z09769
- Z12012
- 4933-0-140 Telescopic Strut Medium Hoffman LRF Length 138-201 mm (Blue) X34352
- Z04200
- Z05068
- Z09011
- Z09598
- Z10872
- 4933-0-180 Telescopic Strut Long Hoffman LRF Length: 177-277 mm (Red)
- X28963
- Z04429
- Z09471
- Z11686
Distribution
Distributed nationwide across the United States.
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