Z-1696-2015Class II

PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument

Name: Z-1696-2015 PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
Creator: Zimmer, Inc.
Published: 2015-04-30
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-04-30 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument on 2015-04-30. FDA classified it as Class II and gives the reason as "Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary...". 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-1696-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-30
Posted: 2015-05-29
Terminated: 2016-03-15
Recalling firm: Zimmer GmbH
Product: PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. Foreign material has been observed on the impactor block. This has the potential for a biological response.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 4/30/2015, URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notifications dated April 30, 2015 were sent to the affected distributors, hospital Risk Managers, and surgeons via courier; all distributors were also notified via electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST.
Quantity in commerce: 1,689
Distribution: Worldwide Distribution-US (nationwide) including PR and the states of AL, AZ, CA, CO, FL, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, and the countries of Canada, Korea, Singapore, Australia, Japan, Malaysia, India, Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Iceland, Iran, Israel, Italy, Norway, Russian Federation, Saudi Arabia, South America, Spain, Sweden, Switzerland, United Kingdom, and United Arab Emirates.
Product codes and lots: Item No. 00-5901-032-00 Lots: 56572845 56574197 56574534 56574775 56575838 56573249 56574198 56574535 56575827 56575839 56573282 56574325 56574536 56575828 56575840 56573283 56574326 56574604 56575829 56576089 56573284 56574327 56574605 56575830 56576090 56573285 56574328 56574606 56575831 56576091 56574130 56574329 56574607 56575832 56576421 56574135 56574530 56574608 56575833 56576429 56574136 56574531 56574617 56575836 56576431 56574137 56574532 56574714 56575837 56576544 56574196 56574533 56574774

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1696-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1696-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-10	2015-05-29

Product code LXH

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)