Z-2232-2018Class II

BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants...

Name: Z-2232-2018 BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants...
Creator: Zimmer Biomet, Inc.
Published: 2018-05-16
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-05-16 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail... on 2018-05-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2232-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-16
Posted: 2018-06-01
Terminated: 2024-04-05
Recalling firm: Zimmer GmbH
Product: BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 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 code: HTY Pin, Fixation, Smooth
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.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 16, 2018 on May 16, 2018, to affected consignees via email and FedEx. The letter describes the product, problem and actions to be taken. Consignees were informed of the recall and instructed to take the following actions: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form must be returned even if you do not have affected products at your facility. Distributor Responsibilities: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. For each return, send a copy of Attachment 1 to [email protected] b. International returns, please request an IRA by emailing [email protected] c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. d. Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to [email protected]. a. Review the list of hospitals included with the email notification sent to your facility, which includes a list of hospitals that have already been notified of this recall. b. Identify whether there are any additional hospitals that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format
Quantity in commerce: 4790
Distribution: Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.
Product codes and lots: 206660 230706 336160 361630 233262 448180 239047 700990 726170 828140 251680 828150 828100 932260 991350 991420 257058 152610 244850 244840 579040 579060 607290 662730 266560 746130 891170 832130 945420 275658 277507 083000 283676 473260 473270 769460 769470 809470 855610 466680 466700 466690 870170 983590 983770 983780 983600 342490 342560 342580 342590 342600 342610 342620 351370 351360 714680 422590 422610 422640 639830 741180 916630 934020 181790 462670 492510 492520 579490 929360 152000 362310 266540 687720 383870 384390 400980 824370 316600 316610 316630 316620 056630 056640 241130 241120 433960 838690 284980 284990 284960 720780 031840 220850 233970 291970 891450 891460 978430 159640 224200 515930 643890 907460 520050 141150 401760 495360 895470 223120 858380 822490 822500 822510 080760 108480 274700 773730 931830 683150 391810 391820 391830 370500 599560 120420 120430 175580 695660 399290 399300 692960 172710 172730 929090 963120 963130

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2232-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2230-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-15
Z-2231-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-15
Z-2232-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-15
Z-2233-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-15
Z-2234-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-15
Z-2235-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-15
Z-2236-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-15
Z-2237-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-15
Z-2238-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-15
Z-2239-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-15
Z-2240-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-15
Z-2241-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-15
Z-2242-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-15

Product code HTY

K831005Class IIWire & Steinman PinsKirschner Medical Corp. / cleared 1983-05-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)