| Date Initiated by Firm |
December 30, 2021 |
| Create Date |
February 17, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0651-2022 |
| Recall Event ID |
89520 |
| 510(K)Number |
K121308
|
| Product Classification |
Prosthesis, hip, femoral component, cemented, metal - Product Code JDG
|
| Product |
Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044 |
| Code Information |
GTIN: 04546540509048; Lot G7900236 |
Recalling Firm/
Manufacturer |
Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
|
| For Additional Information Contact |
Elizabeth Beato
845-260-1849
|
Manufacturer Reason
for Recall |
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.
|
FDA Determined
Cause 2 |
Labeling mix-ups |
| Action |
An URGENT MEDICAL DEVICE RECALL dated 12/30/21 was sent to customers.
Actions Needed:
Our records indicate that you may have received the affected product(s). It is Stryker s responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this 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 made aware.
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.
3. Discontinue use of the recalled Exeter V40 Cemented Hip Stems, Lots #G7900352 and #G7900236 and return the product.
4. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-866-660-8956 or email to strykerortho6067@sedgwick.com.
5. Hospitals Only: Please contact your Local Sales Office or your Stryker Sales Representative directly for product returns and inventory questions.
6. Branches/Agencies Only: Please forward this Urgent Medical Device Recall to the individuals or organizations who have consigned product, if applicable. Return all affected devices available at your location to the following address.
Att. Regina Short (Quality Manager) / PFA# 2847072
Stryker
Global Quality & Operations
Tullagreen Building, IDA Business & Technology Park,
Carrigtwohill, Cork, Ireland
T45 HE42
7. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions.
Please assist us in meeting our regulatory obligation by emailing back the attached Urgent Medical Device Recall Business Reply Form within 5 days. A response is required, even though you may not have any physical inventory on site.
Under 21 CFR 803, manufacturers are also req |
| Quantity in Commerce |
59 devices |
| Distribution |
The product was distributed to the following US states: MI |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = JDG and Original Applicant = HOWMEDICA OSTEONICS CORP
|
