Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 7.5; 00-7713-007-00
Recall
- Recall Number
- Z-2374-2018
- Event Number
- 80188
- Firm
- Zimmer Biomet, Inc.
- FEI Number
- 1000220733
- Product Code
- LPH
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- May 30, 2018
- Terminated
- May 28, 2020
- Address
- 1800 W Center St, Warsaw, IN, 46580-2304
Description
Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 7.5; 00-7713-007-00
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.
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 [email protected] within three (3) days. b. Request a Return Authorization Number by emailing [email protected]. c. For each return, send a copy of Attachment 1 to [email protected]. 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 [email protected]. 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
Products were distributed solely to Japan.
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