Date Initiated by Firm | October 22, 2018 |
Create Date | November 30, 2018 |
Recall Status1 |
Terminated 3 on December 30, 2020 |
Recall Number | Z-0542-2019 |
Recall Event ID |
81394 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
|
Product | Zimmer Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter
Item Number: 00-2228-024-00
Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis. |
Code Information |
All lots expiring prior to September 30, 2023 |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 1800 W Center St Warsaw IN 46580-2304
|
For Additional Information Contact | 411 Technical Services 574-267-6131 |
Manufacturer Reason for Recall | Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility |
FDA Determined Cause 2 | Packaging process control |
Action | Zimmer Biomet conducted recall to distributors and hospital risk managers on 10/22/18, distributors notified via email. Hospital risk managers, as well as distributors with product, will be notified via Fed'X." Distributors responsibilities include:- Locating and removing the product in their territory, as well as identifying hospitals with fielded inventory. Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: Ensuring affected personnel are aware of the notice contents
- Assisting the Zimmer Biomet sales representative with the quarantine of the affected products.
Certificate of Acknowledgement complete and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
Questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday |
Quantity in Commerce | 1676 |
Distribution | Worldwide - US Nationwide Distribution
Foreign:
CANADA
AUSTRALIA
BRAZIL
CHILE
HONG KONG
JAPAN
MALAYSIA
NETHERLANDS
NICARAGUA
SINGAPORE
TAIWAN |
Total Product Life Cycle | TPLC Device Report |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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