Food, drugs, devices › Howmedica Osteonics Corp.
Device recall: Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
Howmedica Osteonics Corp. (Mahwah, NJ) initiated this device recall on 3 Oct 2019; FDA lists 1 product record under event 84148, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 21 Apr 2022. Initiation: voluntary: firm initiated. Howmedica Osteonics Corp. has 48 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Howmedica Osteonics Corp., Mahwah, NJ.
Reason for recall
"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)"
Distribution
"Foreign: Australia, France, Finland, Germany, Italy, Japan, New Zealand, Netherlands, Norway, Romania, Spain, Sweden and UK"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0514-2020 | Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025 | 40 units | Class II | Terminated | 4 Dec 2019 |
Context
Other enforcement events for Howmedica Osteonics Corp.
All 48 events for Howmedica Osteonics Corp.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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)"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Foreign: Australia, France, Finland, Germany, Italy, Japan, New Zealand, Netherlands, Norway, Romania, Spain, Sweden and UK"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Apr 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.