Z-0734-2019Class II

Maximum Variable Pitch Compression Tray Base, Reference Number 231201002

Name: Z-0734-2019 Maximum Variable Pitch Compression Tray Base, Reference Number 231201002
Creator: Zimmer Biomet, Inc.
Published: 2018-11-28
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-11-28 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory... on 2018-11-28. FDA classified it as Class II and gives the reason as "There is a potential for silicone shedding during cleaning and sterilization". 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-0734-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-28
Posted: 2019-01-14
Terminated: 2020-05-12
Recalling firm: Zimmer GmbH
Product: Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals
Product code: FSM Tray, Surgical, Instrument
Reason for recall: There is a potential for silicone shedding during cleaning and sterilization.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Urgent Medical Device Correction notification letters dated 11/28/18 were distributed to customers. The letter identified the affected product, problem and actions to be taken.
Quantity in commerce: 971 i nTotal
Distribution: Worldwide Distribution - US Nationwide, The products were distributed to the following foreign countries: Australia, Chile, Netherlands.
Product codes and lots: Lot Numbers 453392 453918 453919 469917 475577 481064 481065 486820 498695 506818 512868

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0734-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0734-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-23	2019-01-14
Z-0735-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-23	2019-01-14

Product code FSM

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)