Z-2084-2012Class II

Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17...

Name: Z-2084-2012 Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2011-12-22
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2011-12-22 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ 07401. During primary Scorpio TKA... on 2011-12-22. FDA classified it as Class II and gives the reason as "Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted into the slot of the Tibial Punch Tower. The slot that guides the stem of the keel punch into the channel of the tower was...". 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-2084-2012
Classification: Class II
Status: Terminated
Initiated: 2011-12-22
Posted: 2012-07-26
Terminated: 2013-06-13
Recalling firm: Howmedica Osteonics Corp
Product: Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ 07401. During primary Scorpio TKA procedures, the Scorpio Tibial Punch Tower (8000-1089) is used in conjunction with Scorpio Tibial Keel Punches (3760-0305/-0709/-1113 and 3761-0305/-0709/-1113) and Tibial Templates (3750-0003/-0005/-0007/-0009/-0013) to prepare the tibia for baseplate implantation. Per the surgical protocol for Duracon and Scorpio Total Knee Systems with Xcelerate Instrumentation (LSPK31 03/03), tibial templates are used to determine the appropriate coverage of the tibial plateau. Once a template size is selected, the device is secured to the plateau with fixation pins, and the tibial punch tower is assembled by placing the tower onto the two small locating pins on the tibial template. A keel punch is then selected, assembled into the channel of the tower, and impacted with a mallet. Depending on the intended implant size, several keel punches of increasing size may be utilized to incrementally enlarge the cavity. Each keel punch is advanced until it fully seats on the tibial template. Tibial preparation is considered complete when the final keel punch fully seats on the tibial template.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted into the slot of the Tibial Punch Tower. The slot that guides the stem of the keel punch into the channel of the tower was later determined to be undersized.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Stryker Orthopaedics sent an Urgent Product Recall/Recall Acknowledgement letter dated January 10, 2012, to all affected customers. The letter identified the product(s) the problem and the action needed to be taken by the customer. Customers were instructed to contact their Stryker Sales Representative to arrange for return of the affected product. Customers were asked to fax back the attached Product Recall Acknowledgement Form as soon as possible to 201-831-6069. For questions customers should call 201-972-2100. For questions regarding this recall call 201-831-5970.
Quantity in commerce: 152 units
Distribution: Worldwide Distribution
Product codes and lots: Catalog Number 8000-1089. Lot Number(s): RD6E087, RD6E187; RD6E083; RD6E082; RD6C178; RD5W268; RD5W267; RD5V260; RD5W320; RD5V240; RD5V239; RD5V238; RD5N407; RD5S104; RD5S103; RD5T177; RD5T179; RD5S259; RD5T178; RD5N406; RD5S300; RD5T298; RD5W381; RD6E086; RD6E089; RD6E090; RD6E091; RD6E158; RD6E159; RD6E160; RD6E186.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2084-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2084-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-26

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