Food, drugs, devices › Stryker Corporation
Device recall: CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI dev
Stryker Corporation (San Jose, CA) initiated this device recall on 25 Jan 2018; FDA lists 1 product record under event 79030, 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Stryker Corporation has 37 enforcement events on this register, with a median of 2 product records 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
Stryker Corporation, San Jose, CA.
Reason for recall
"The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit."
Distribution
"Netherlands"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0974-2018 | CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small quantities of glycosaminoglycans (GAGs:… | 155 devices | Class II | Ongoing | 21 Mar 2018 |
Context
Other enforcement events for Stryker Corporation
All 37 events for Stryker Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit."
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: "Netherlands"
Is the recall still ongoing?
FDA lists the status as Ongoing. "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.