Surgical Drill System Instrument Pack Recalled Over Device Breakage Risk
Wright Medical is recalling 176 packs of the EasyFuse Dynamic Compression System Instrument Pack due to risk that the drill guide can jam and break 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 3/5 (High).
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: This is an FDA Class II recall of a surgical instrument with a documented mechanical failure risk (jam/bind resulting in guide breakage during intraoperative use). However, the source text does not report any actual injuries, deaths, or hospitalizations, so per the severity rubric the score is limited to High.
Plain-English summary
Wright Medical Technology, Inc. is recalling 176 packs of the EasyFuse Dynamic Compression System Instrument Pack (Model Number FFSP1530) due to a mechanical defect. The affected products were distributed to healthcare facilities in Florida, North Carolina, Ohio, and Texas. Affected lot codes are 781853-110321 (expiration 11/03/2029) and 780395-112221 (expiration 12/03/2029).
The drill and adjustable drill guide can jam or bind during surgical procedures, resulting in the drill guide breaking.
Healthcare facilities and patients should stop using the affected instrument packs immediately. Contact Wright Medical Technology for information about replacement or return of the affected products.
The recalled product
- Product
- EasyFuse Dynamic Compression System Instrument Pack
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 176
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)
- Model Number FFSP1530
Distribution
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