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.
What this means for you
Illness, injury, or structural failure has been reported. 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 fi
- 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.
Related recalls
Same manufacturer · Stryker Howmedica Osteonics Corp.
See all →- HighStryker Recalls Hoffmann LRF Safety Clips Due to Loosening Risk
FDA (Devices) · 2017-05-31
- ModerateStryker Recalls Kirschner Wires Due to Potential Sterile Pouch Seal Failure
FDA (Devices) · 2016-12-28
- SevereStryker Recalls LFIT Anatomic V40 Femoral Heads Due to Taper Lock Failure
FDA (Devices) · 2016-11-16
- HighStryker Orthopaedics Recalls Universal Acetabular Cup Positioner/Impactor
FDA (Devices) · 2016-10-19
- HighStryker Patella Assembly Instrument Recalled for Component Disassociation Risk
FDA (Devices) · 2016-09-21
Same hazard · structural failure
See all →- SevereMondraker Recalls Mountain Bicycles with ONOFF S9 Carbon Handlebars
CPSC · 2026-09-03
- HighFord F-650 SD Recall: Liftgate Platform Deck Pins May Break
NHTSA · 2026-08-20
- HighStryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization
FDA (Devices) · 2026-08-05
- HighStryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization
FDA (Devices) · 2026-08-05
- High