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Comprehensive SRS / Discovery recallZ-1173-2018 · Biomet, Inc. · initiated Feb 28, 2018

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected]. 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 [email protected]. ***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.

Recall details

Recall number
Z-1173-2018
Status
Terminated
Initiated by the company
Feb 28, 2018
Posted by the FDA
Mar 23, 2018
Recalling firm
Biomet, Inc.
Quantity
634
Product code
KWT
FDA submissions
K111746
Distribution
Distribution US Nationwide

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

Model numbers: 211250 211251 211252 211253 211254 211255  Lot codes: 095580 119120 130020 142530 155910 162450 162460 241160 257860 304290 305860 309730 337610 389790 400730 419380 430570 443670 545430 546260 548290 550390 586120 606830 611540 636370 636470 688540 704020 714760 793670 806070 829520 829530 881230 950270 970920 019600 110780 130040 157180 185620 203520 241180 278580 330870 364380 424550 430580 457210 544340 583360 636520 706690 714810 810260 853250 881330 883830 891880 923660 923680 991400 033700 053800 062210 110790 160770 185630 241190 247810 257870 347080 583370 611530 636680 638640 674650 688550 775020 829540 848530 889330 950310 976390 988380 991410 028450 028460 053810 062220 098020 155900 160780 231490 241230 251120 251920 257880 281140 330880 347100 367850 400390 450780 493220 494170 527200 546290 548460 548470 548580 586130 611520 636710 665880 704030 761210 829550 853260 889810 914750 923670 923690 925920 927420 937130 991320 062830 119130 130070 185590 196660 201270 241290 247280 247290 257890 338480 347110 350590 366310 554450 636760 648150 704040 714830 750840 767880 793710 829560 878430 927430 948090 952960 970930 976410 040470 192770 241300 258540 288580 293740 320100 340150 347700 364660 419900 442840 462480 462490 569770 611040 611930 688560 770690 780490 815100 818160 829690 867530 891270 923980 924160 927440 201270 848530 976410 033700 350590 554450  ***Lots added 3/31/2020*** Item Number 211253 - Lot Number 434480 - UDI (1)00880304850330(17)280423(10)434480  Item Number 211251 - Lot Number 434470 - UDI (1)00880304850316(17)280507(10)434470

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

22 devices cleared under K111746 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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