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Terminated

VHS Pediatric Hip Screw System Ped VHS, Lag Screw Ref # 200516 Stainless Steel, Rx only

FDA Recall Z-0180-2007 · Posted 2006-11-15

Recalling FirmEBI, L.P.
Recall StatusTerminated
Product CodeKTT
Date Initiated2006-09-06
Date Terminated2007-02-21
Product Quantity1117 in distributor inventory, 205 implanted, 1372 in manufacturer's control

Reason for Recall

VHS Plate and lag screw components did not assemble correctly intraoperatively.

Firm Action

Recall notification was sent out by US mail on 9/6/2006 indicating the lot number(s) of product received.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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