|
Class 2 Device Recall Corin METAFIX HIP STEM |
 |
Date Initiated by Firm |
July 22, 2022 |
Create Date |
August 09, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1509-2022 |
Recall Event ID |
90573 |
510(K)Number |
K153381 K082525
|
Product Classification |
Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
|
Product |
Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103 |
Code Information |
UDI (01) 0 505563 89123 0 (10) 485630 (17) 261114, Lot Number 485630 |
Recalling Firm/ Manufacturer |
Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom
|
For Additional Information Contact |
441285659866
|
Manufacturer Reason for Recall |
One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
|
FDA Determined Cause 2 |
Process control |
Action |
The firm notified its direct consignees of the recall on 07/22/2022 by letter. The notice explained the issue and requested the following actions:
"Actions to be taken by the Customer:
- Quarantine the devices if not yet performed
- Return the devices to Corin Limited, displaying the RGA note on the exterior of the parcel, to:
RA/Vigilance Department; Corin Ltd; Corinium Centre; Cirencester; Gloucestershire; GL7 1YJ, United-Kingdom
- Complete the acknowledgement of receipt and forward it to the Vigilance department of Corin UK to confirm receipt of this Field Safety Notice/Recall letter." |
Quantity in Commerce |
5 devices |
Distribution |
US Nationwide distribution in the states of OK, TX, FL. |
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 = JDI and Original Applicant = CORIN USA 510(K)s with Product Code = JDI and Original Applicant = Corin USA Limited
|
|
|
|