FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp.: Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
- Recall number
- Z-0514-2020
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
- Status
- Terminated
- Initiated
- 2019-10-03
- Posted
- not on file
- Terminated
- 2022-04-21
- Reason
- Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)
- Root cause
- Employee error
- Action
- Stryker issued An Urgent Field Safety Notice (FSN), PFA 2197654, was issued to all affected OUS consignees at country level on October 03, 2019. Action to take: Actions to be taken by the Customer/ User: 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 are at your facility. A response is required, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Complete customer response form and return the form and any affected devices to the following address. (Please complete this form regardless of whether your organization has product to return. This will preclude the need for Stryker to send any reminder notice.) ATTN: David Nihill, Limerick Finished Goods Centre C/O Flextronics Global Services Ireland Unit 1 Raheen Business Park Raheen, Limerick.
- Quantity
- 40 units
- Distribution
- Foreign: Australia, France, Finland, Germany, Italy, Japan, New Zealand, Netherlands, Norway, Romania, Spain, Sweden and UK
- Lot, serial or model codes
- Lot Number: G6091225, Exp. Date: 2022-06 UDIs: (01)04546540167712(17)220618(10)
- 510(k) numbers
- ["K121308"]
- PMA numbers
- not on file
- Product code
- LPH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- 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
- 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