Recall Z-2261-2018
Paragon 28, Inc. · initiated December 19, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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, 260326217F and 260326217G.
Reason for recall
Missing drill guide as stated in the package.
FDA-determined cause: Error in labeling
Action taken
The firm, Paragon 28 Inc. sent an "MEDICAL DEVICE RECALL" letter dated Dec 19, 2017 to their consignees. The letter describes the product, problem and actions to be taken. The consignees were instructed to immediately review their inventory to determine if they have the devices; if you have possession of any of the devices, you must ship entire kit back to Paragon 28 Inc., 96 Inverness Drive, E. ste 1; Englewood CO 80112. If you have any questions, contact Senior Quality Manager at 720-643-1301 or email to: epohl@paragon28.com.
Details
- Recall number
- Z-2261-2018
- Initiated
- December 19, 2017
- Terminated
- January 15, 2021
- Product code
- JDR – Staple, Fixation, Bone
- Quantity
- 1,626
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI; to countries of: Australia and South Africa.
- Recalling firm
- Paragon 28, Inc., Englewood, CO