Pro-Med Instruments Recalls DORO Sterile Disposable Skull Pins Due to Breakage
Pro-Med Instruments is recalling DORO Sterile Disposable Skull Pins because two instances of pin tip breakage were reported 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: The recall is classified as FDA Class II, and the hazard involves a structural failure of a surgical device during use, which poses a risk of harm to patients, although specific injury reports are not detailed in the source text.
Plain-English summary
Pro-Med Instruments Gmbh is recalling DORO(R) Sterile Disposable Skull Pins. The recall involves 1,142 units from lots 17041 and 17272. These medical devices are used to fixate the head during surgery by inserting into the receptacles of a skull clamp.
The recall was initiated after the firm received reports of two breakages of the pin tips. Both incidents occurred during identical surgery procedures, with the breakage happening at the very distal end of the conical part of the skull pin tip.
The affected products were distributed nationwide in the United States and internationally to Germany, Saudi Arabia, France, the United Kingdom, Australia, Austria, Ireland, South Africa, Hungary, India, Spain, Italy, Japan, and Canada. Healthcare providers and patients should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.
- Manufacturer
- Pro-Med Instruments Gmbh
- Affected units
- 1,142
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)
- Lots: 17041 and 17272
Distribution
Distributed nationwide across the United States.
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