Z-2241-2018Class II

RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of implants (cannulated...

Name: Z-2241-2018 RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of implants (cannulated...
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 RECON DRILL 6MM X 439MM; 14-443023 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-2241-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-16
Posted: 2018-06-01
Terminated: 2024-04-05
Recalling firm: Zimmer GmbH
Product: RECON DRILL 6MM X 439MM; 14-443023 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: 248
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: 001360 008170 106320 330040 952200 924770 446470 446480 337720 032750 971520 957780 295550

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2241-2018
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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)