Z-1197-2018Class II

AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5...

Name: Z-1197-2018 AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5...
Creator: Zimmer Biomet, Inc.
Published: 2018-02-06
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-02-06 / Terminated

FDA source

Zimmer Biomet, Inc. began a recall of AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 27.0 810508285 NAIL TIB... on 2018-02-06. FDA classified it as Class II and gives the reason as "The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1197-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-06
Posted: 2018-03-14
Terminated: 2019-04-02
Recalling firm: Zimmer GmbH
Product: AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 27.0 810508285 NAIL TIB DYN 08 X 28.5 810508300 NAIL TIB DYN 08 X 30.0 810508315 NAIL TIB DYN 08 X 31.5 810508330 NAIL TIB DYN 08 X 33.0 810508345 NAIL TIB DYN 08 X 34.5 810508360 NAIL TIB DYN 08 X 36.0 810508375 NAIL TIB DYN 08 X 37.5 810508390 NAIL TIB DYN 08 X 39.0 810508405 NAIL TIB DYN 08 X 40.5 810508420 NAIL TIB DYN 08 X 42.0 810509255 NAIL TIB DYN 09 X 25.5 810509270 NAIL TIB DYN 09 X 27.0 810509285 NAIL TIB DYN 09 X 28.5 810509300 NAIL TIB DYN 09 X 30.0 810509315 NAIL TIB DYN 09 X 31.5 810509330 NAIL TIB DYN 09 X 33.0 810509345 NAIL TIB DYN 09 X 34.5 810509360 NAIL TIB DYN 09 X 36.0 810509375 NAIL TIB DYN 09 X 37.5 810509390 NAIL TIB DYN 09 X 39.0 810509405 NAIL TIB DYN 09 X 40.5 810509420 NAIL TIB DYN 09 X 42.0 810510255 NAIL TIB DYN 10 X 25.5 810510270 NAIL TIB DYN 10 X 27.0 810510285 NAIL TIB DYN 10 X 28.5 810510300 NAIL TIB DYN 10 X 30.0 810510315 NAIL TIB DYN 10 X 31.5 810510330 NAIL TIB DYN 10 X 33.0 810510345 NAIL TIB DYN 10 X 34.5 810510360 NAIL TIB DYN 10 X 36.0 810510375 NAIL TIB DYN 10 X 37.5 810510390 NAIL TIB DYN 10 X 39.0 810510405 NAIL TIB DYN 10 X 40.5 810510420 NAIL TIB DYN 10 X 42.0 810511255 NAIL TIB DYN 11 X 25.5 810511270 NAIL TIB DYN 11 X 27.0 810511285 NAIL TIB DYN 11 X 28.5 810511300 NAIL TIB DYN 11 X 30.0 810511315 NAIL TIB DYN 11 X 31.5 810511330 NAIL TIB DYN 11 X 33.0 810511345 NAIL TIB DYN 11 X 34.5 810511360 NAIL TIB DYN 11 X 36.0 810511375 NAIL TIB DYN 11 X 37.5 810511390 NAIL TIB DYN 11 X 39.0 810511405 NAIL TIB DYN 11 X 40.5 810511420 NAIL TIB DYN 11 X 42.0 810512270 NAIL TIB DYN 12 X 27.0 810512285 NAIL TIB DYN 12 X 28.5 810512300 NAIL TIB DYN 12 X 30.0 810512315 NAIL TIB DYN 12 X 31.5 810512330 NAIL TIB DYN 12 X 33.0 810512345 NAIL TIB DYN 12 X 34.5 810512360 NAIL TIB DYN 12 X 36.0 810512375 NAIL TIB DYN 12 X 37.5 810512390 NAIL TIB DYN 12 X 39.0 810512405 NAIL TIB DYN 12 X 40.5 810512420 NAIL TIB DYN 12 X 42.0 810513255 NAIL TIB DYN 13 X 25.5 810513285 NAIL TIB DYN 13MM X 28.5CM 810513300 NAIL TIB DYN 13MMX30.0 CM 810513315 NAIL TIB DYN 13MM X 31.5 CM 810513330 NAIL TIB DYN 13 X 33.0 810513345 NAIL TIB DYN 13MM X 34.5 CM 810513360 NAIL TIB DYN 13 X 36.0 MM 810513375 NAIL TIB DYN 13MM X 37.5 CM 810513390 NAIL TIB DYN 13MMX39.0CM 810513405 NAIL TIB DYN 13MM X 40.5 CM 810513420 NAIL TIB DYN 13MM X 42 CM Product Usage: A metal rod which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. This device is non-sterile and must be sterilized prior to use. It is a single-use device.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
FDA root cause: Under Investigation by firm
Action: Zimmer Biomet sent an Urgent Medical Device Recall letter dated February 06, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Review this notification and notify affected personnel of the contents. 2. Quarantine all affected product. Your Zimmer Biomet sales representative will remove it from your facility. 3. Complete the Certificate of Acknowledgement and send to [email protected]. DISTRIBUTOR: 1. Review this notification and notify affected team members of the contents.2. Quarantine affected product in your inventory. 3.Return affected product from your distributorship and from affected hospitals within your territory. a. Complete Inventory Return Certification Form and send to [email protected] within three (3) days. b. International returns, request an International Return Authorization (IRA) Number by emailing [email protected] 4. Return the Additional Accounts form to [email protected].
Quantity in commerce: Not known
Distribution: Worldwide and US of Indiana and country of the Republic of Korea.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1197-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1196-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-26
Z-1197-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-26

Product code HSB

K972183Class IIDepuy Ace A.i.m. Titanium Tibial NailAce Medical Co. / cleared 1997-08-26

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)