Stryker Spine Recalls Reliance AL Implant Blocker Due to Prong Breakage
Stryker Spine is recalling Reliance AL Implant Blockers because six reports indicated that prongs on the instruments broke during use.
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 involves a medical device with reported mechanical failure (prong breakage) during use, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Stryker Spine is recalling the Reliance AL Implant Blocker, a reusable surgical instrument used to distract the disc space in the lumbar spine. The recall involves 109 lots of the device, which are distributed nationwide across multiple states including North Carolina, Arkansas, Tennessee, Massachusetts, Illinois, Georgia, New York, Louisiana, Minnesota, Missouri, Ohio, Kansas, New Mexico, Texas, and Indiana.
The recall was initiated after Stryker Spine received six reports regarding the breakage of one or more prongs at the extremity of the instrument. The device is sterilized prior to use and allows surgeons to insert implants into their final position using an anterior or anterolateral approach.
Healthcare facilities and distributors should stop using the affected lots immediately. Stryker Spine is the recalling firm responsible for managing the recall of these specific catalog and lot numbers.
The recalled product
- Product
- Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use. It allows the surgeon to distract the disc space in the lumbar region of the spine using an anterior or anterolateral approach while also allowing
- Manufacturer
- Stryker Spine
- Hazard
- Affected units
- 109
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 (11)
- Catalog Number: 48361223
- 48361224
- 48361225
- 48361226
- 48361227
- 48361228 Lot Code: 084505
- 084506
- 084507
- 084508
- 084509
- 084510
Distribution
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