Date Initiated by Firm | February 27, 2024 |
Date Posted | April 25, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1625-2024 |
Recall Event ID |
94215 |
510(K)Number | K171768 |
Product Classification |
Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
|
Product | TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 702-11-54E |
Code Information |
UDI-DI:(01)07613327380880(17)290313(10)
Lot Number:
15293151
15293153
15293152
15432252
15432254
15432451
15432351
15432251
15432253
16265752
|
Recalling Firm/ Manufacturer |
Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2006
|
For Additional Information Contact | Loriann Russo 201-831-5000 |
Manufacturer Reason for Recall | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Stryker issued Urgent Medical Device Recall (UMDR) PFA 3529813 by Sedgwick on Feb. 27, 2024, via UPS 2-day air. An OUS customer notification will also be issued at the country level.
Letter states reason for recall and action to take:
Technical and medical assessments are currently underway to determine any potential hazards and harms associated with the use of an impacted Trident II Acetabular Shell.
An updated communication will be forwarded upon completion of the internal investigation of this issue.
1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product.
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. Quarantine and discontinue use of the recalled devices identified in the affected product list.
4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to " Medical Facility: Please sign the Business Reply Form and email to:
strykerortho4091@sedgwick.com / Fax: (833) 237-1022
" Stryker Branch/Agency: please sign the AdobeSign form arriving to you via email.
5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions.
6. Please return the devices to Stryker using the following address:
Stryker Orthopaedics/PFA Product Returns
Attn: Distribution Inventory Team
325 Corporate Drive
Dock M-East
Mahwah, NJ 07430
Ref. PFA 3529813
If you have any questions or concerns after reviewing
this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email
SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com |
Quantity in Commerce | 225 units |
Distribution | Nationwide
Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK |
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 = LPH
|