Paragon 28 Recalls P28 JAWS Nitinol Staple Kits Due to Missing Drill Guide
Paragon 28, Inc. is recalling P28 JAWS Nitinol Staple System kits because the drill guide is missing from the package.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a missing component (drill guide) which is a packaging/labeling issue rather than a direct contamination or structural defect causing immediate harm, fitting the criteria for moderate severity.
Plain-English summary
Paragon 28, Inc. is recalling 1,626 units of P28 JAWS Nitinol Staple System kits. These kits are designed for use in osteotomy, arthrodesis, and fragment fixation of bones and joints of the foot, including the fixation of small bone fragments.
The recall was initiated because the drill guide, which is stated in the package, is missing. The affected products include specific part numbers and lots of 8mm and 10mm straight and angled staples.
The products were distributed nationwide in the United States to specific states and internationally to Australia and South Africa. Users should stop using the affected kits and contact the manufacturer for instructions.
The recalled product
- Product
- P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.
- Manufacturer
- Paragon 28, Inc.
- Hazard
- Affected units
- 1,626
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 (20)
- Part # P71-008-0808-S 8mm x 8mm x 8mm
- Straight Lots 260315217A
- 260322017A
- 260326217A and 260326217B.
- Part # P71-010-1010-S 10mm x 10mm x 10mm
- Straight Lots 260317717A
- 260317717C
- 260322017B
- and 260326217D.
- Part # P71-108-0808-S 8mm x 8mm x 8mm
- Angled
- Lots 260322017C
- 260322017D
- 260315217B
- and 260326217M. and Part # P71-110-1010-S 10mm x 10mm x 10mm
- Angled Lots 260326217E
- 260317717B
- 260322017E
- 260322017F
- 260322017G
Distribution
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