| Date Initiated by Firm |
January 13, 2022 |
| Create Date |
March 01, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0706-2022 |
| Recall Event ID |
89522 |
| Product Classification |
Appliance, fixation, spinal interlaminal - Product Code KWP
|
| Product |
Everest MI XT Outer Dilator, Catalog Number 5101-90168 |
| Code Information |
GTIN: 10888857261211;
Lot Numbers: HCBN
HCBP
JUJJ
KFMX
KUPH
KYYV
MDPF
NAKJ
NDGT
PCCN |
Recalling Firm/
Manufacturer |
K2M, Inc
600 Hope Pkwy SE
Leesburg VA 20175-4428
|
| For Additional Information Contact |
Regulatory Compliance
201-4798090
|
Manufacturer Reason
for Recall |
Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
|
FDA Determined
Cause 2 |
Process control |
| Action |
URGENT: MEDICAL DEVICE RECALL notification letters dated 1/13/22 were sent to customers.
Hospital Quality or Materials Managers/Inventory Contacts instructions:
Actions needed
1. Immediately check your internal inventory to locate the product listed on the attached Business Reply
Form and remove them from their point of use.
2. Use the Business Reply Form to reconcile any affected product. Complete the Business Reply Form even
if there is no affected product identified.
3. Return the enclosed Business Reply Form by email to Spine-RegulatoryActions@Stryker.com or fax to 201-
575-4675 to confirm receipt of this notification/document product segregation. Your account s Stryker
Spine Sales Representative will arrange for retrieval and removal of any instruments associated with this
recall.
4. In the interim, until units can be removed from your facility by Stryker, there are no additional actions that users can and should take once the product has been segregated and removed from point of use.
- If you desire additional training associated with these instructions, please contact our Regulatory Compliance team by calling 201.749.8090 or by email at Spine-RegulatoryActions@Stryker.com, or contact your local Sales representative.
5. Maintain awareness of this communication internally until all required actions have been completed within your facility.
6. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately.
7. Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Stryker informed of any adverse events associated with this product by using Stryker s online reporting site: https://www.stryker.com/productexperience. Additionally, adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adver |
| Quantity in Commerce |
686 Total Devices |
| Distribution |
Worldwide distribution - US Nationwide. |
| 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.
|
