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Nail Insertion Sleeve, elastic T2 Tibia SPI 8-11 (SPI… recallZ-2171-2021 · Stryker GmbH · initiated May 27, 2021

Open, Classified

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 GmbH 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

The devices have a different inner diameter than the diameter specified on the outer box label.

FDA root cause category: Process control

What the company is doing

An URGENT MEDICAL DEVICE RECALL notice dated 5/27/21 was sent to customers. Actions to be Taken by the Customer/User: Our records indicate that you may have received one or more of the affected products. It is Strykers responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important communication. We therefore request that you read this notice carefully and complete the following actions. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list is at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. Return the devices back to Stryker. 4. Under 21 CFR 803, manufactures are also required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Stryker informed of any adverse events associated with this product by emailing [email protected]. 5. A response is required, even though you may not have any physical inventory on site anymore. 6. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-888-879-4609 or email to [email protected]. 7. Hospitals Only: Please contact your Local Sales Office or your Stryker Sales Representative directly for product returns and inventory questions. 8. Branches/Agencies Only: Return all affected devices available at your location to the following address. Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 2644769 Please assist us in meeting our regulatory obligation by faxing back the attached Urgent Medical Device Recall Business

Recall details

Recall number
Z-2171-2021
Status
Open, Classified
Initiated by the company
May 27, 2021
Recalling firm
Stryker GmbH
Quantity
242
Product code
HSB
FDA submissions
K131365
Distribution
US Nationwide Distribution

Product description

Nail Insertion Sleeve, elastic T2 Tibia SPI 8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S

Code information (models, lots, serial numbers)

GTIN 04546540715357, Lot Number K03CC4F

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 88240).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page