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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85524

13 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 17, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Biomet, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

13 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 13

Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usage: is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.

Z-2144-2020
Recall number
Z-2144-2020
Initiated
April 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
122 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential presence of elevated endotoxin levels that exceed the specification limit

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential presence of elevated endotoxin levels that exceed the specification limit

Code information

Lot Numbers: 1)597000 UDI (01)00880304462489(17)211229(10)597000 2) 502510 UDI (01)00880304475458(17)211229(10)502510 3) 744880 UDI (01)00880304475434(17)220117(10)744880

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.

device · product 2 of 13

Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26 Product Usage: Hemi hip arthroplasty.

Z-2145-2020
Recall number
Z-2145-2020
Initiated
April 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
58 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential presence of elevated endotoxin levels that exceed the specification limit

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential presence of elevated endotoxin levels that exceed the specification limit

Code information

Lot Numbers: UDI Number 1) 752470 (01)00880304568785(17)220118(10)752470 854070 (01)00880304568785(17)220119(10)854070; 2) 094360 (01)00880304209688(17)220106(10)094360; 3) 588500 (01)00880304209688(17)220106(10)094360

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.

device · product 3 of 13

Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis

Z-2146-2020
Recall number
Z-2146-2020
Initiated
April 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential presence of elevated endotoxin levels that exceed the specification limit

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential presence of elevated endotoxin levels that exceed the specification limit

Code information

Lot Numbers: UDI Number 1) 561760 (01)00880304554412(17)211229(10)561760; 2) 091090 (01)00880304506084(17)211214(10)091090

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.

device · product 4 of 13

Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis

Z-2147-2020
Recall number
Z-2147-2020
Initiated
April 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential presence of elevated endotoxin levels that exceed the specification limit

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential presence of elevated endotoxin levels that exceed the specification limit

Code information

Lot Numbers: UDI Number 292720 (01)00880304006492(17)211222(10)292720

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.

device · product 5 of 13

Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4 154339 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D7 154355 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, B3 154361 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, C4 154366 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, D4 154370 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, E3 154375 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F3 154375 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F3 154376 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F4 154376 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F4 154377 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F5 159575 Oxford Partial Knee System Anatomic Meniscal Bearing, Right Medial, Medium, 3 MM Product Usage: Knee prosthesis

Z-2148-2020
Recall number
Z-2148-2020
Initiated
April 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
76 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential presence of elevated endotoxin levels that exceed the specification limit

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential presence of elevated endotoxin levels that exceed the specification limit

Code information

Lot Numbers: Product UDI Number 666130 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 (01)05019279515226(17)211226(10)666130 570480 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4 (01)05019279515240(17)211223(10)570480 589030 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D7 (01)05019279515301(17)211226(10)589030 602820 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, B3 (01)05019279515493(17)211226(10)602820 328350 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, E3 (01)05019279515646(17)211223(10)328350 560530 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F3 (01)05019279999453(17)211226(10)560530 827910 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F3 (01)05019279999453(17)211224(10)827910 786780 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F4 (01)05019279999460(17)211226(10)786780 602860 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F5 (01)05019279999477(17)211223(10)602860 374340 Knees Oxford Partial Knee System Anatomic Meniscal Bearing, Right Medial, Medium, 3 MM (01)05019279786213(17)211228(10)374340 374340 Oxford Partial Knee System Anatomic Meniscal Bearing, Right Medial, Medium, 3 MM (01)05019279786213(17)211228(10)374340

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.

device · product 6 of 13

Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM 155344 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 75 MM 155346 Knees AGC Knee System PS Molded Tibial Component, 12 MM X 75 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155328 Knees AGC Knee System PS Molded Tibial Component, 12 MM X 70 MM 155388 Knees AGC Knee System PS Molded Tibial component, 18 MM X 85 MM Product Usage: Knee prosthesis

Z-2149-2020
Recall number
Z-2149-2020
Initiated
April 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
54 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential presence of elevated endotoxin levels that exceed the specification limit

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential presence of elevated endotoxin levels that exceed the specification limit

Code information

Lot Numbers: UDI Number 570460 AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM (01)00880304000865(17)220111(10)570460 515880 AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM (01)00880304000193(17)220106(10)515880 602810 AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM (01)00880304246034(17)220105(10)602810 494090 AGC Knee System PS Molded Tibial Component, 10 MM X 75 MM (01)00880304003781(17)220106(10)494090 505320 AGC Knee System PS Molded Tibial Component, 12 MM X 75 MM (01)00880304246096(17)220106(10)505320 578470 AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM (01)00880304000193(17)220114(10)578470 447820 AGC Knee System PS Molded Tibial Component, 12 MM X 70 MM (01)00880304000179(17)220118(10)447820 494030 AGC Knee System PS Molded Tibial component, 18 MM X 85 MM (01)00880304246256(17)220118(10)494030

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.

device · product 7 of 13

Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM 189048 Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM 189082 Vanguard Knee System, AS Tibial Bearing, 12 MM X 75 MM

Z-2150-2020
Recall number
Z-2150-2020
Initiated
April 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
46 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential presence of elevated endotoxin levels that exceed the specification limit

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential presence of elevated endotoxin levels that exceed the specification limit

Code information

Lot Numbers: UDI Number 443160 Knees Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM (01)00880304271869(17)211230(10)443160 458440 Knees Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM (01)00880304271852(17)220105(10)458440 376090 Knees Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM (01)00880304436947(17)220113(10)376090 678080 Knees Vanguard Knee System, AS Tibial Bearing, 12 MM X 75 MM (01)00880304436954(17)220119(10)678080

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.

device · product 8 of 13

Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM 189700 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 79 MM 189704 Vanguard Knee System, CR Mono Lock Tibial Bearing, 14 MM X 79 MM Product Usage: Knee prosthesis

Z-2151-2020
Recall number
Z-2151-2020
Initiated
April 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
11 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential presence of elevated endotoxin levels that exceed the specification limit

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential presence of elevated endotoxin levels that exceed the specification limit

Code information

Lot Numbers: UDI Number 630770 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304448490(17)211228(10)630770 646170 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304448490(17)211227(10)646170 530980 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM (01)00880304556140(17)211228(10)530980 570570 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM (01)00880304448605(17)220106(10)570570 477430 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 79 MM (01)00880304493131(17)220115(10)477430 505490 Vanguard Knee System, CR Mono Lock Tibial Bearing, 14 MM X 79 MM (01)00880304556119(17)220115(10)505490

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.

device · product 9 of 13

Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM 189442 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189440 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189426 Vanguard Knee System, PS Mono Lock Tibial Bearing, 16 MM X 63 MM 189440 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM

Z-2152-2020
Recall number
Z-2152-2020
Initiated
April 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
107 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential presence of elevated endotoxin levels that exceed the specification limit

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential presence of elevated endotoxin levels that exceed the specification limit

Code information

Lot Numbers: UDI Number 530900 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM (01)00880304451735(17)211223(10)530900 548950 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM (01)00880304451360(17)211222(10)548950 602870 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM (01)00880304451360(17)211228(10)602870 530930 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM (01)00880304451346(17)211223(10)530930 588890 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM (01)00880304451346(17)211223(10)588890 602930 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM (01)00880304451346(17)211228(10)602930 697510 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM (01)00880304451346(17)211227(10)697510 700830 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM (01)00880304451346(17)211228(10)700830 530940 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)211223(10)530940 758560 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)211228(10)758560 758580 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)211223(10)758580 884710 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)211229(10)884710 570620 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)220106(10)570620 884680 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)220107(10)884680 828010 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220106(10)828010 855380 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220111(10)855380 855390 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220111(10)855390 772740 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM (01)00880304451735(17)220112(10)772740 796110 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM (01)00880304451735(17)220115(10)796110 796120 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM (01)00880304451735(17)220112(10)796120 796150 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220112(10)796150 828040 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220115(10)828040 830730 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220115(10)830730 727060 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM (01)00880304451735(17)220121(10)727060 505430 Vanguard Knee System, PS Mono Lock Tibial Bearing, 16 MM X 63 MM (01)00880304454859(17)220125(10)505430 581950 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)220121(10)581950 608380 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)220118(10)608380 644080 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)220118(10)644080 708620 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM (01)00880304451308(17)220121(10)708620 758570 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM (01)00880304451322(17)220118(10)758570

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.

device · product 10 of 13

Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM 183744 Vanguard Knee System, PS+ Tibial Bearing, 14 MM, 71/75 MM 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM Product Usage: Knee prosthesis

Z-2153-2020
Recall number
Z-2153-2020
Initiated
April 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
93 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential presence of elevated endotoxin levels that exceed the specification limit

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential presence of elevated endotoxin levels that exceed the specification limit

Code information

Lot Numbers: UDI Number 294130 Knees Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM (01)00880304438262(17)211219(10)294130 509970 Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)211230(10)509970 509990 Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)220103(10)509990 175980 Knees Vanguard Knee System, PS+ Tibial Bearing, 14 MM, 71/75 MM (01)00880304438354(17)220114(10)175980 294130R Knees Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM (01)00880304438262(17)211219(10)294130R 509970R Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)211230(10)509970R 509990R Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)220103(10)509990R

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.

device · product 11 of 13

Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM Product Usage: Knee prosthesis

Z-2154-2020
Recall number
Z-2154-2020
Initiated
April 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
91 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential presence of elevated endotoxin levels that exceed the specification limit

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential presence of elevated endotoxin levels that exceed the specification limit

Code information

Lot Numbers: UDI Number 508390 Vanguard Knee System, Series-A Standard Patella, 28 MM (01)00880304431638(17)211218(10)508390; 309810 Vanguard Knee System, Series-A Standard Patella, 31 MM (01)00880304431317(17)211228(10)309810

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.

device · product 12 of 13

Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D5 US154725 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6 US154705 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B6 US154707 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B7 US154713 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C5 US154719 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C8 US154720 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D4 US154721 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D4 US154723 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D5 US154725 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6 US154727 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D7 US154727 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D7 US154731 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, E4 US154735 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, E6 US154745 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, A6 US154745 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, A6 US154746 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, A7 US154711 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C4 US154734 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, E6 US154730 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, E4 US154711 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C4 Product Usage: Knee prosthesis

Z-2155-2020
Recall number
Z-2155-2020
Initiated
April 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
105 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential presence of elevated endotoxin levels that exceed the specification limit

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential presence of elevated endotoxin levels that exceed the specification limit

Code information

Lot Numbers: UDI Number 570440 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 (01)00880304180703(17)211219(10)570440 548700 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D5 (01)00880304180833(17)211219(10)548700 560400 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6 (01)00880304180864(17)211221(10)560400 630710 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B6 (01)00880304180666(17)211223(10)630710 570430 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B7 (01)00880304180680(17)211226(10)570430 690010 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C5 (01)00880304180741(17)211220(10)690010 560370 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C8 (01)00880304180802(17)211226(10)560370 630720 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D4 (01)00880304180819(17)211226(10)630720 548690 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D4 (01)00880304180826(17)211227(10)548690 560390 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D5 (01)00880304180840(17)211227(10)560390 570450 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6 (01)00880304180864(17)211223(10)570450 548720 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D7 (01)00880304180888(17)211226(10)548720 560410 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D7 (01)00880304180888(17)211227(10)560410 697350 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, E4 (01)00880304180925(17)211223(10)697350 615650 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, E6 (01)00880304180963(17)211226(10)615650 560420 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, A6 (01)00880304181069(17)211223(10)560420 630740 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, A6 (01)00880304181069(17)211228(10)630740 570420 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, A7 (01)00880304181076(17)211228(10)570420 463400 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C4 (01)00880304180727(17)211229(10)463400 630700 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, E6 (01)00880304180956(17)220107(10)630700 697340 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, E4 (01)00880304180918(17)220116(10)697340 455810 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C4 (01)00880304180727(17)220119(10)455810

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.

device · product 13 of 13

Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee prosthesis

Z-2156-2020
Recall number
Z-2156-2020
Initiated
April 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential presence of elevated endotoxin levels that exceed the specification limit

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential presence of elevated endotoxin levels that exceed the specification limit

Code information

Lot Number/UDI: 735550 (01)00841036226534(17)220111(10)735550

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.