Z-3203-2017Class II

Drill Bit Quick-Connect 3.2 mm Diameter 195 mm Length, Item Number/EDI 00480619532, Nonsterile. orthopedic...

Name: Z-3203-2017 Drill Bit Quick-Connect 3.2 mm Diameter 195 mm Length, Item Number/EDI 00480619532, Nonsterile. orthopedic...
Creator: Zimmer Biomet, Inc.
Published: 2017-05-22
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-05-22 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of Drill Bit Quick-Connect 3.2 mm Diameter 195 mm Length, Item Number/EDI 00480619532, Nonsterile. orthopedic surgical instrument on 2017-05-22. FDA classified it as Class II and gives the reason as "Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3203-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-22
Posted: 2017-09-22
Terminated: 2019-03-29
Recalling firm: Zimmer GmbH
Product: Drill Bit Quick-Connect 3.2 mm Diameter 195 mm Length, Item Number/EDI 00480619532, Nonsterile. orthopedic surgical instrument.
Product code: HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Reason for recall: Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 5/22/2017, Zimmer Biomet distributed Urgent Medical Device Recall notices to their customers and distributors. On 12/19/2017, Zimmer Biomet sent Urgent Medical Device Recall notices to their customers due to a recall expansion involving one (1) lot for product # 20. Customers are advised to review the notice and ensure that affected personnel are aware of the contents. All stock should be inspected and product quarantined. A Zimmer Biomet sales representative will remove the affected product from your facility. Customers should complete and return the Certificate of Acknowledgement via email to: [email protected] and retain the copy for your files. Customers with questions may call the customer call center at 574-371-3071, Monday through Friday 8 am - 5 pm, EST. *For Distributors Your Responsibilities include the following: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form. a. Return a digital copy to [email protected] within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet. a. For each return, send a copy of the completed acknowledgement form via email to: [email protected]. b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Include a copy of Attachment 3 Certificate of Sterilization with returned instruments. d. Mark the outside of the returns box(es) clearly with FIELD ACTION. 5. Note that any hospitals that received direct shipments of this product from Zimmer Biomet will be sent a copy of the Risk Manager Field Action Notice direc
Quantity in commerce: 75 units
Distribution: Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
Product codes and lots: Lot Numbers: 63570253, 63574369, 63584044, 63622717 & 63634109.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3203-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3144-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3145-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3146-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3147-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3148-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3149-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3150-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3151-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3152-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3153-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3154-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3155-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3156-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3157-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3158-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3159-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3160-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3161-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3162-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3163-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3164-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3165-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3166-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3167-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3168-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3169-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3170-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3171-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3172-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3173-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3174-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3175-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3176-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3177-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3178-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3179-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3180-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3181-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3182-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3183-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3184-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3185-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3186-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3187-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3188-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3189-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3190-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3191-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3192-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3193-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3194-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3195-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3196-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3197-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3198-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3199-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3200-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3201-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3202-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22
Z-3203-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22

Product code HWE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)