Z-0137-2016Class II

Thinflap System Case The cases hold surgical instrumentation in place during handling and storage

Name: Z-0137-2016 Thinflap System Case The cases hold surgical instrumentation in place during handling and storage
Creator: Biomet Microfixation, LLC
Published: 2015-08-06
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2015-08-06 / Terminated

FDA source

Biomet Microfixation, LLC began a recall of Thinflap System Case The cases hold surgical instrumentation in place during handling and storage on 2015-08-06. FDA classified it as Class II and gives the reason as "The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0137-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-06
Posted: 2015-10-20
Terminated: 2017-10-13
Recalling firm: Biomet Microfixation
Product: Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
Product code: GWO Plate, Cranioplasty, Preformed, Alterable
Reason for recall: The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
FDA root cause: Component change control
Action: Biomet Microfixation made phone calls on August 6, 2015 and an initial notice letter sent via FedEx on August 6, 2015, to all distributors. During the phone conversation the distributors confirmed that the inventory invoiced to them is currently in their possession and were asked to remove the lids from the trays and return them back to Biomet Microfixation. In conjunction to the Initial Notice, replacement lids were sent to their business address. Followup communication would be distributed until all units are returned to Biomet Microfixation. Distributors were instructed to do the following: 1. Immediately locate and remove from circulation the items invoiced to your account as identified on this notice. 2. Remove the lids from the quarantined units and replace with the lids (15-5001-18 or 19-5001-18) received with this Initial Notice. The new lids are being distributed to address the issue with the trays. 3. Return the lids removed from the quarantined units to Zimmer Biomet CMF and Thoracic team with the labeling information provided with this notice. RETURN THIS LID: lot number(101337 or 101~65) located on the back of the lid DO NOT RETURN NEW LID: Part numbert 15-5001-18 or 1~5001-18 respectively 4. Use the FedEx label in this packet to return the lids; this will be Zimmer Biomet's method of tracking your return. If distributors have further distributed this product, they must notify the recipient of this action by providing the recipient a copy of this notice. This letter must be given to the personnel responsible for receiving field safety notices. Please understand it is your responsibility to locate and quarantine these products. Customers with questions were instructed to call at 1-800-874-7711 or 904-741-4400, extension 9574, Monday through Friday, 8am-4pm ET.
Quantity in commerce: 5 units
Distribution: Nationwide Distribution including CA, FL, OK, NY, NC, and IL.
Product codes and lots: Lot Code # 101465 Model # 19-5000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0137-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0136-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-20
Z-0137-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-20

Product code GWO

K121624Class IIBiomet Microfixation Neuro Plating SystemBiomet Microfixation / cleared 2012-10-12

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)