Z-1238-2018Class II

Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block...

Name: Z-1238-2018 Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block...
Creator: Zimmer Biomet, Inc.
Published: 2017-11-29
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-11-29 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model... on 2017-11-29. FDA classified it as Class II and gives the reason as "Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle". 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-1238-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-29
Posted: 2018-03-28
Terminated: 2019-04-05
Recalling firm: Zimmer GmbH
Product: Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10; (4) 12mm block, Model Number: 42-5399-035-12; (5) 14mm block, Model Number: 42-5399-035-14 A spacer block is used to ensure the tibial resection Is sufficient and to verify limb alignment. After verification the distal femoral resecUon Is complete using the distal femoral cut slot in the spacer block. The spacer block determines how much distal femoral bone is resected.
Product code: HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Reason for recall: Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Zimmer Biomet sent an Urgent Medical Device Correction Recall letter dated November 29, 2017. RISK MANAGER PHASE I: 1. Review this notification and notify affected personnel of the contents. 2. Product does not need to be returned at this time. You will receive a follow-up notice when the removal phase is initiated (Phase 2). If you identify a spacer block that will not assemble with these instruments, and you are unwilling to use the spacer block without this functionality, the spacer block may be returned to your sales representative. 3. Complete Certificate of Acknowledgement (Phase 1) and send to [email protected]. SURGEON PHASE I: 1. Review this notification for awareness of the contents. 2. The spacer block may be used without the alignment tower and inserted and removed by hand from the joint, without the Persona Partial Knee handle. If you identify a spacer block that will not assemble with these instruments, and you are unwilling to use the spacer block without this functionality, the spacer block may be returned to your sales representative. 3. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 4. Complete Certificate of Acknowledgement (Phase 1) and send to [email protected]. DISTRIBUTOR PHASE I: 1. Review this notification and notify affected team of the contents. 2. Product does not need to be returned at this time. You will receive a follow-up notice when the removal phase is initiated. 3. Should you or your account prefer to perform a functional check, this may be done by using the instructions in the surgical technique for assembling the alignment tower and handle to the spacer block. If you or your account identify a spacer block that will not assemble with these instruments, and the user is unwilling to use the spacer block without this functionality, the spacer block may be returned as a complaint to Pr
Quantity in commerce: 1023
Distribution: USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI., and Internationally to Japan and Netherlands.
Product codes and lots: (1) 8mm block, Model Number: 42-5399-035-08, Lots: 63767442 and 63807190; (2) 9mm block, Model Number:42-5399-035-09, Lot: 63769804; (3) 10mm block, Model Number: 42-5399-035-10, Lot: 63769805; (4) 12mm block, Model Number: 42-5399-035-12, Lot: 63769806; (5) 14mm block, Model Number: 42-5399-035-14, Lots: 63767443 and 63813674

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1238-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1238-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27

Product code HSX

K161592Class IIPersona Partial Knee SystemBiomet, Inc. / cleared 2016-11-03

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)