| Date Initiated by Firm |
May 30, 2018 |
| Create Date |
July 05, 2018 |
| Recall Status1 |
Terminated 3 on May 28, 2020 |
| Recall Number |
Z-2369-2018 |
| Recall Event ID |
80188 |
| Product Classification |
Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
|
| Product |
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15; 00-7713-015-00
|
| Code Information |
61288759 61542760 61710043 61729725 61735130 61768446 61805951 61843648 61874222 61950885 61957017 61967640 61967642 61985977 62010557 62014550 62059104 62124960 62134980 62153554 62163677 62191383 62225911 62270944 62273474 62275220 62275874 62316364 62329143 62356225 62418056 62420829 62420831 62420832 62432973 62472159 62503173 62521423 62521424 62521425 62521426 62540539 62571382 62578409 62652963 62659314 62659315 62667476 62700958 62721036 62739979 62761717 62776407 62787314 62787315 62794382 62815408 62836783 62836785 62885067 62939020 62939021 62939023 63044942 63051893 63063344 63063345 63063346 63063348 63068961 63068965 63068967 63068969 63076579 63076580 63081284 63081286 63090043 63090044 63094542 63102029 63102030 63108843 63174078 63174079 63174081 77004214 61429027R 62066989R 62335432R 62836786R |
Recalling Firm/
Manufacturer |
Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
|
| For Additional Information Contact |
411 Technical Services
574-371-3071
|
Manufacturer Reason
for Recall |
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
|
FDA Determined
Cause 2 |
Packaging |
| Action |
On May 30, 2018, the firm emailed Urgent Medical Device Recall letters to its Japanese subsidiary, who then further distributed the letters locally to Distributors and Risk Managers in Japan. The letter informed affected consignees of the product issue. Customers were instructed to do the following:
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. Request a Return Authorization Number by emailing zimmerbiometintlirarequests@zimmerbiomet.com.
c. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
d. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
e. Mark RECALL on the outside of the returned cartons.
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
If you have further questions or concerns after reviewing this information, please call Zimmer Biomet customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call r |
| Quantity in Commerce |
1024 |
| Distribution |
Products were distributed solely to Japan. |
| 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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