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iBur recallZ-2725-2024 · Stryker Corporation · initiated Jul 24, 2024

Completed

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.

FDA root cause category: Under Investigation by firm

What the company is doing

Stryker issued Urgent Medical Device Recall letter on 7/24/424 to Materials Manager, Risk Manager, OR Director via Fed'x. Letter states reason for recall, health risk, and action to take: 1. Immediately review your inventory to locate and quarantine any affected products at your facility. 2. Return the enclosed Business Reply Form (BRF), even if the affected product is no longer in inventory, to the email [email protected]. 3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand. 4. A credit will be provided upon receipt of the recalled product. 5. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. If you have any questions about this matter, contact Stryker Instruments by phone (269) 568-1481 or email at [email protected].

Recall details

Recall number
Z-2725-2024
Status
Completed
Initiated by the company
Jul 24, 2024
Posted by the FDA
Aug 26, 2024
Recalling firm
Stryker Corporation
Quantity
2507 units
Product code
HBE
FDA submissions
K210377
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, France, Hong Kong, India, Italy, Japan, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, United Kingdom.

Product description

Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-012-030D

Code information (models, lots, serial numbers)

GTIN: 7613327501230 Lot Numbers: 22216017 22230017 22334017 23004017 23004027 23009017 23157017 23208017 23233017 23233027 24003017

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 95040).

Sources and updates

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