Recall Z-0524-2020
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
Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
Codes / lots: 062090 062100 062110 062120 104880 116920 119760 973400 973410 062130 104890 933090 933100 933110 062140 502750 933120 933130 044510 045880 045890 202520 502780 109560 689770 710510 710520 736700 736710 762300 762310 781930 781940 806540 806550 838070 838080 853100 853110 870190 870200 886220 886230 901510 901520 933070 933080 948630 948640 689780 710530 710540 736720 736730 762320 762330 781950 781960 781970 806560 806570 806580 838090 838100 838110 853120 853130 870210 870220 886240 886250 901530 901540 689790 710550 710570 736740 736750 762340 762350 781990 782000 806590 806610 838120 838130 853140 853150 870230 870240 886260 886270 901550 901560 015610 015620 156580 689820 710580 710590 736760 736770 762360 782010 782020 806620 806630 838140 838150 853160 853170 870260 870270 886290 886300 901570 901580 933150 933160 948650 948660 973420 973430 994730 994740
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-0524-2020
- Initiated
- August 21, 2019
- Terminated
- July 21, 2021
- 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-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-0527-2020 Class II | Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643…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 |