Stryker Recalls Reunion TSA Peg Alignment Sound Due to Breakage
Stryker Howmedica Osteonics Corp. is recalling 131 units of the Reunion TSA Peg Alignment Sound because the instrument broke during surgery.
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 failure of a medical device during surgery, which aligns with the rubric criteria for a Severe rating.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 131 units of the Reunion TSA Peg Alignment Sound (Catalog #5901-1038, Revision A). This instrument is used in the ReUnion TSA shoulder system to confirm the seating height and peg alignment of the TSA Self-Pressurizing Polyethylene Glenoid implant before it is placed in the glenoid vault.
The recall was initiated because the instrument broke during surgery. The affected units were distributed nationwide.
Healthcare providers should stop using the affected instruments and contact Stryker Howmedica Osteonics Corp. for further instructions on the recall.
The recalled product
- Product
- Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA Self-Pressurizing Polyethylene Glenoid implant prior to…
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 131
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 (1)
- Catalog #5901-1038
Distribution
Distributed nationwide across the United States.
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