Recall Z-0527-2020
Zimmer Biomet, Inc. · initiated August 21, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
Codes / lots: All lots manufactured between January 2008 - May 2019: 197000 838570 047410 869160 047400 047390 203030 203040 224470 482850 052950 076580 917420 326610 362350 565380 374150 420170 374160 882210 882090 746150 691040 969190 942350 726180 048880 385080 111310 013150 868010 638680 745730 780270 780240 013140 834290 623340 817490 028380 186120 409420 847030 679990 755600 409330 706270 169490 936000 400990 343410 235880 917410 872790 715870 179470 313330 324140 362650 305750 326590 920210 564070 305740 632120 684640 536380 564770 014640R 745910 629320 629350 014640 807570 946770 111280 946800 735450 108390 370610 385070 884110 013160 884080 621660 919220 836010 645380 706600 899340 712500 838730 963630 021010 896300 673910 669190 146510 613110 678830 335900 684340 106100 105780 140000 447810 154700 911280 363670 102500 931980 519820 114830 762310 076570 296510 917390 096130 059170 362810 552990 684260 587040 565220 484880 634740 485340 414520 906620 808780 678310 969290 013240 013250 014670 014850 384890 108310 808790 561410 808770 336710 018410 617860 313520 378380 579070 566190 927200 297800 673900 348320 702090 939400 736230 268220 055290 347210 347230 342820 725450 817310 153990…
Reason for recall
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
FDA-determined cause: Environmental control
Action taken
On September 11, 2019, the firm began notifying distributors and customers of the recall via an Urgent Medical Device Recall letter. The letter informed consignees of the product issue. Customers were asked to assist their Zimmer Biomet sales representative and quarantine all identified product. The sales representative will remove the product from your facility. If any products were further distributed, please forward the notification to responsible parties. If you have further questions or concerns, please call customer service at 574-371-3071 between 8:00 am and 5:00 pm ET, 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. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.
Details
- Recall number
- Z-0527-2020
- Initiated
- August 21, 2019
- Terminated
- July 21, 2021
- Product code
- MBF – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- Quantity
- 219988 units (total)
- Distribution
- US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.
- Recalling firm
- Zimmer Biomet, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0519-2020 Class II | Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0520-2020 Class II | COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0521-2020 Class II | ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0522-2020 Class II | HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)664…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0523-2020 Class II | Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0524-2020 Class II | Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/AElevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0525-2020 Class II | Comprehensive RS Cleat CAP, Item No. 110300Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0526-2020 Class II | Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0528-2020 Class II | HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0529-2020 Class II | GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0530-2020 Class II | BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0531-2020 Class II | 2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0532-2020 Class II | LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0533-2020 Class II | BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |