Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2242-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

Product Classification:

Class II

Date Initiated: May 16, 2018

Date Posted: June 27, 2018

Recall Number: Z-2242-2018

Event ID: 80193

Reason for Recall:

The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.

Status: Terminated

Product Quantity: 2396

Code Information:

631960 668040 668020 668030 668050 668060 265460 265450 322270 354190 370190 918470 034780 101840 216280 135720 327770 363260 389080 389070 399500 436760 436770 471160 471170 005620 244600 403100 791030 791110 839790 898930 898940 898960 974090 974100 974060 974070 974080 038580 142780 142790 492260 522530 205310 767140 492270 341690 620450 118270 418780 107090 373830 600950 609070 044210 044220 612900 683640 683630 507830 675290 284100 132110 962210

Distribution Pattern:

Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated