Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 18055...
FDA Device Recall #Z-0619-2021 — Class II — November 25, 2020
Recall Summary
| Recall Number | Z-0619-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 25, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Biomet, Inc. |
| Location | Warsaw, IN |
| Product Type | Devices |
| Quantity | 7428 |
Product Description
Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthroplasty and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff The patient must anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
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.
Distribution Pattern
Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
Lot / Code Information
Lots 208000 270240 270260 208010 214760 270290 270300 270310 484060 484150 208130 155060 208270 472020 193140 193200 193220 193300 272150 272290 354260 354350 497880 497910 497930 497970 498680 498690 498700 509140 214470 214490 214500 214520 154290 154300 154360 272530 498790 498800 498860 498870 154420 154430 214610 272620 272680 354050 354090 354110 354120 354130 354150 498880 498890 498910 498920 498940 498960 214630 214640 214650 272730 376710 625850 214660 353570 272770 272840 353600 499060 625860 625870 625880 625900 214700 351300 352990 353620 353650 214710 214720 214730 353230 353240 353270 353280 353300 214740 272920 353310 353340 353350 214750 353370
Other Recalls from Biomet, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0212-2026 | Class II | BIOMET ZipTight, Acute AC Joint Implant, Single... | Sep 23, 2025 |
| Z-2619-2025 | Class II | Juggerknot Mini Soft Anchors, Model/Catalog Num... | Sep 9, 2025 |
| Z-0477-2025 | Class II | JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model nu... | Oct 21, 2024 |
| Z-2179-2024 | Class II | RingLoc Bi-Polar Hip System Acetabular Cup, 41 ... | May 17, 2024 |
| Z-1607-2024 | Class II | Vanguard Knee System AS Tibial Bearing / DCM Ar... | Mar 13, 2024 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.