Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 1805
FDA device recall Z-0619-2021 · posted 2020-12-17 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
- Action taken
- On November 25, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed of the potential loss of sterility in affected devices. Customers were asked 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. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. All customers should also complete the certificate of acknowledgement included with the letter and return to the firm. 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KWS
- Quantity affected
- 7428
- Distribution
- Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
- Date initiated
- 2020-11-25
- Date posted
- 2020-12-17
- Date terminated
- 2024-05-08
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ComprehensiveĀ® Reverse Shoulder (K193373) | Biomet, Inc. | 2020-04-15 |
| COMPREHENSIVE CONVERTIBLE GLENOID (K130390) | Biomet Manufacturing, Inc. | 2013-10-09 |
| COMPREHENSIVE REVERSE SHOULDER SCREWS (K132239) | Biomet Manufacturing Corp | 2013-09-06 |