Myriad handpieces recalled because packaging tape contains undisclosed latex
Stryker is recalling 39,148 NICO Myriad Handpieces because tape used to secure components in the packaging contains latex despite the products being labelled latex-free.
What this means for you
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: Scored 3 under the risk-of-harm criterion: undisclosed latex in a product labelled latex-free can trigger an allergic reaction, and no injuries are reported.
Plain-English summary
The NICO Myriad Handpiece is being recalled across product numbers NN-8000 through NN-8008, covering the 15x10, 15x13, 15x25, 13x10, 13x13, 11x10 and 11x13 configurations including MINOP and GAAB variants.
Tape used to secure components within the packaging contains latex, despite the products being labelled as latex-free. Stryker states latex could potentially cause an allergic reaction.
The recall covers 39,148 units, including GTIN 00816744028008 for NN-8000, across lots including 37BH1415, 37CB3768, 37DC0517 and 37EB6074. Distribution was worldwide, including nationwide in the United States and to Australia, Belgium, Canada, England, Ireland and Italy. The FDA has classified the action as Class II.
A latex-free label is exactly what a latex-allergic patient or clinician relies on. The enforcement record reports no injuries. Facilities should quarantine affected lots and follow Stryker's instructions.
The recalled product
- Product
- NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-8005 15x25 MHP GAAB; NN-8006 11X10 MHP; NN-8007 11x13 MHP; NN-8008 19x28 MHP OI; NN-8010 17x31.
- Manufacturer
- Stryker Corporation
- Affected units
- 39,148
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 (7)
- NN-8500 00816744025007 37AC5392 37DC9515 37DJ1044 37HI1634 37IJ1007 37KI1920
- NN-8505 00816744025052 37AC4878 37DI2629 37DJ1048 37HJ1103 37IA7312
- NN-8508 00816744025083 37CI1917 37CJ2215 37HB9031 37IC6878 37JJ0610
- NN-8510 00816744025106 37BJ1835 37CB4112 37FC3097 75KI2225
- NN-8518 00816744025182 37GA4637 37HB9032 37KJ1717 37LJ1532
- NN-8519 00816744025199 37BC7418 37FD0159 37HC4981 37JI1556 37LC1691
- NN-8520 00816744025205 37CC7851 37HD2770 37IC6879
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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