Tibial Punch Tower Assembly — Class II medical device recall Z-2084-2012
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2012-08-01. Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted into the slot
| Recall number | Z-2084-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2011-12-22 |
| Classified | 2012-07-26 |
| Reported by FDA | 2012-08-01 |
| Terminated | 2013-06-13 |
| Quantity | 152 units |
| Lot numbers | RD5N406, RD5N407, RD5S103, RD5S104, RD5S259, RD5S300, RD5T177, RD5T178, RD5T179, RD5T298, RD5V238, RD5V239, RD5V240, RD5V260, RD5W267, RD5W268, RD5W320, RD5W381, RD6C178, RD6E082, RD6E083, RD6E086, RD6E087, RD6E089, RD6E090, RD6E091, RD6E158, RD6E159, RD6E160, RD6E186, RD6E187 |
| Model numbers | 8000-1089 |
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.
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.