FDA Medical Device Recalls (openFDA)
Stryker GmbH: Nail Insertion Sleeve, elastic T2 Tibia SPI 8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
- Recall number
- Z-2171-2021
- Recalling firm
- Stryker GmbH
- Product
- Nail Insertion Sleeve, elastic T2 Tibia SPI 8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
- Status
- Open, Classified
- Initiated
- 2021-05-27
- Posted
- not on file
- Terminated
- not on file
- Reason
- The devices have a different inner diameter than the diameter specified on the outer box label.
- Root cause
- Process control
- Action
- 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 soprodexpreports@stryker.com. 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 StrykerOrtho8434@Stericycle.com. 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
- Quantity
- 242
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- GTIN 04546540715357, Lot Number K03CC4F
- 510(k) numbers
- ["K131365"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3002807830
- Firm city
- Selzach
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28