Recall Z-0528-2020 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Zimmer Biomet, Inc.
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-1
| Date | Aug 21, 2019 |
| Status | Terminated |
| Reason | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. |
| Root cause | Environmental control |
| Action | 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 throug |
| Quantity | 178886 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003397 | COLLES C SERIES FRAME STERILE PACK DePuy Orthopaedics, Inc., Jan 29, 2001 |
| K013503 | MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR DePuy Orthopaedics, Inc., Nov 16, 2001 |
| K081244 | LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS Biomet Trauma, Jul 30, 2008 |
| K992367 | EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS Electro-Biology, Inc., Sep 23, 1999 |