Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Di

FDA device recall Z-1173-2018 · posted 2018-03-23 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly during surgery. If the product has already been implanted, no action is required. The mismatch is estimated to prevent screw engagement in less than 1% of cases.

Action taken

An URGENT MEDICAL DEVICE RECALL letter will be issued to customers titled "Affected Product: Comprehensive Segmental Revision System (SRS)" instructing customers to do the following: 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 the attached 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. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further 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. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. ***Updated 3/31/2020*** On March 31, 2020, Zimmer Biomet expanded the recall to include two additional lots: Lot 434480 (for Item No. 211253) and Lot 434470 (for Item No. 211251). Customer instructions remain the same.

Root cause

Under Investigation by firm

Status

Terminated

Product code

KWT

Quantity affected

634

Distribution

Distribution US Nationwide

Date initiated

2018-02-28

Date posted

2018-03-23

Date terminated

2020-08-11

Location

Warsaw, IN

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