Synthes Recalls Mislabelled PRODISC Orthopedic Spinal Surgery Struts
Synthes (USA) Products LLC is recalling two PRODISC Orthopedic Manual Surgical Instrument struts used in spinal surgery because they are incorrectly etched and labeled with the wrong size.
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: The recall involves a medical device with a labeling error that could lead to the use of the wrong size instrument during surgery, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Synthes (USA) Products LLC is recalling two units of the PRODISC Orthopedic Manual Surgical Instrument, specifically struts used in spinal surgery to hold the disc segment open and facilitate discectomy. The affected items are part numbers 03.820.350 (lot 5919005) and 03.820.352 (lot 5919006). These instruments were distributed in the United States to Texas and Louisiana.
The recall is due to incorrect etching and labeling. The item etched and labeled as a 10mm Strut (03.820.350) is actually a 12mm Strut. Conversely, the item etched and labeled as a 12mm Strut (03.820.352) is actually a 10mm Strut. This mislabeling could lead to the use of the wrong size instrument during surgery.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment open and facilitate discectomy
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 2
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 (2)
- Part numbers 03.820.350 Lot 5919005 and 03.820.352
- lot 5919006
Distribution
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