—#184774

Product

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.

FDA product code: KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K130390, K132239, K193373
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

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

Timeline

Recall initiated: 2020-11-25
Posted by FDA: 2020-12-17
Terminated: 2024-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184774. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.