FDA Medical Device Recalls (openFDA)
Tornier, Inc: stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
- Recall number
- Z-3155-2024
- Recalling firm
- Tornier, Inc
- Product
- stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
- Status
- Open, Classified
- Initiated
- 2024-08-29
- Posted
- 2024-09-16
- Terminated
- not on file
- Reason
- One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
- Root cause
- Under Investigation by firm
- Action
- Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via mail and email. The notice explained the issue, potential risk, and requested the following actions be taken: identify and isolate all affected product to prevent accidental use, and complete and return the response form. Upon receipt, Stryker will contact the consignee and arrange for the return of the product. Distributor were directed to notify their customers. Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via mail and email. The notice explained the issue, potential risk, and requested the following actions be taken: identify and isolate all affected product to prevent accidental use, and complete and return the response form. Upon receipt, Stryker will contact the consignee and arrange for the return of the product. Distributors were directed to notify their customers. For questions or concerns, please contact memphis.fieldaction@stryker.com.
- Quantity
- 5 units
- Distribution
- US Nationwide distribution in the states of IL, WI, AZ, NV, SD.
- Lot, serial or model codes
- UDI/DI 00846832092192, Lot number 3268BA
- 510(k) numbers
- ["K220418"]
- PMA numbers
- not on file
- Product code
- PKC
- Firm FEI
- 3000718467
- Firm city
- Bloomington
- Firm state
- MN
- Firm country
- not on file
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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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