Stryker Recalls Baseplate Impactor Extractor Instruments Due to Handle Detachment
Stryker Howmedica Osteonics is recalling 871 Baseplate Impactor Extractor instruments because the handle may detach from the cam during surgery.
What this means for you
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: The recall is classified as FDA Class II, and the hazard involves a mechanical failure (handle detachment) during a surgical procedure, which presents a risk of harm to patients even though specific injuries are not detailed in the source text.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 871 units of the Baseplate Impactor Extractor TRIATHLON Instruments. The recall is being conducted because Stryker received field reports indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly.
The affected instruments are intended to securely attach to the tibial baseplate or baseplate trial for impaction and extraction during surgery. The recall covers units distributed worldwide, including the United States, Canada, Japan, Australia, China, New Zealand, France, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, and the United Kingdom.
Healthcare providers and facilities should identify affected units by checking the catalog number 6541-4-805 and the specific lot numbers listed in the recall documentation. Users should stop using the affected instruments and contact Stryker Howmedica Osteonics for further instructions on the recall process.
The recalled product
- Product
- Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 871
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 (20)
- Catalog Number 6541-4-805. Lot Numbers: RD4V204
- RD5V234
- RD5V235
- RD5V235A
- RD5V235Y
- RD5V236
- RD5V236A
- RD5V237
- RD6A009
- RD6A010
- RD6A011
- RD6A011P
- RD6A012
- RD6A051
- RD6A052
- RD6A053
- RD6A053M
- RD6A053T
- RD6A061
- RD6A061A
Distribution
Distributed nationwide across the United States.
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